206 Jobs für Quality Assurance in Schweiz

Quality für den Schweizer Markt – GMP, GDP, Freigaben, Audits

Unser Kunde ist ein etabliertes Schweizer Pharmaunternehmen mit hoher Reputation, moderner Produktion und einem vielseitigen Portfolio an pharmazeutischen Produkten. Die gesamte Wertschöpfung – von der Entwicklung bis zur Markteinführung – erfolgt aus einer Hand. Für die Stärkung des QA-Bereichs suchen wir eine erfahrene Fachperson als
Fachtechnisch verantwortliche Person (FvP)
.

Ihre Rolle – Verantwortung mit Wirkung

In dieser zentralen Teamleitungsfunktion übernehmen Sie als gemeldete FvP bei Swissmedic die Verantwortung für:

• Marktfreigabe & technische Freigaben
  von Arzneimitteln gemäß GMP/GDP-Regularien
• Audit Management:
  Planung, Durchführung und Nachbereitung externer Audits inkl. API-Hersteller und Lieferantenqualifizierung
• SOPs & Schulungen:
  Entwicklung bereichsspezifischer Richtlinien und Training interner QA-Teams
• Vertretung des Head Quality Systems
  und enge Zusammenarbeit mit der Geschäftsleitung
• Unterstützt werden Sie von zwei erfahrenen Kolleginnen im operativen Tagesgeschäft.

Was Sie mitbringen

• Naturwissenschaftliches Studium (MSc, PhD)
• Berufserfahrung in der Herstellung oder QA von Solida oder Semi Solida
• Idealerweise: Anerkennung als FvP oder mehrjährige Tätigkeit als stv. FvP/QP
• Tiefes Verständnis pharmazeutischer Prozesse, hohe GMP/GDP-Kompetenz
• Selbständige, strukturierte und prozessorientierte Arbeitsweise
• Sehr gute Deutsch- und Englischkenntnisse

Was Sie erwartet

• Eine verantwortungsvolle Rolle mit hoher Sichtbarkeit im Unternehmen
• Gestaltungsspielraum in einem innovationsfreundlichen Umfeld
• Kurze Entscheidungswege, direkte Berichtslinie zur Geschäftsleitung
• Ein kollegiales, eingespieltes Team und attraktive Rahmenbedingungen
• Standort im Großraum Zürich – mit guter Erreichbarkeit und moderner Infrastruktur

Ihr nächster Schritt

Sie möchten Ihre FvP-Erfahrung in einem stabilen und zugleich dynamischen Umfeld einbringen? Dann freuen wir uns auf Ihre Kontaktaufnahme.

Bewerben Sie sich jetzt – und übernehmen Sie Verantwortung für Qualität, Sicherheit und Vertrauen.

Job Title:
Quality Manager – Product Development

Location:
Lausanne

Job Type:
Full-time

Job Summary:

We are seeking a highly skilled and detail-oriented
Quality Manager
to lead our quality assurance efforts across the product development lifecycle.

Key Responsibilities:

• Develop and implement quality management strategies aligned with product development goals.
• Establish and maintain quality standards, processes, and KPIs throughout the product lifecycle.
• Ensure compliance with relevant international standards (ISO 9001, ISO/IEC 27001, etc.).
• Lead internal and external audits; manage certifications and regulatory requirements.
• Define and optimize QA processes (e.g., testing, defect tracking, release criteria).
• Promote continuous improvement initiatives using Lean Six Sigma methodologies.
• Work closely with engineering, product management, UX, and operations teams to embed quality into all phases of product development.
• Participate in design reviews, code inspections, and risk assessments.
• Foster a culture of quality, accountability, and continuous learning across the organization.
• Track, analyze, and report quality metrics (e.g., defect density, test coverage, cycle time).
• Use data to drive decision-making and present insights to leadership.

Requirements:

• Bachelor's degree in Engineering, Computer Science, Quality Management, or related field.
• 8+ years of experience in quality assurance or quality management within the tech or software development industry.
• Strong knowledge of industry standards such as
  ISO 9001
  ,
  ISO/IEC 27001
  ,
  CMMI
  , etc.
• Hands-on experience with
  Six Sigma
  ,
  Lean
  , or other quality improvement frameworks.
• Proficiency with QA tools and platforms (e.g., JIRA, TestRail, Selenium, etc.).
• Deep understanding of Agile, Scrum, or other modern development methodologies.
• Exceptional analytical, problem-solving, and organizational skills.
• Strong communication and leadership capabilities.

Preferred Qualifications:

• Six Sigma Green Belt or Black Belt certification.
• Lead Auditor certification for ISO standards.

What We Offer:

• A collaborative and innovative work environment.
• Opportunity to shape quality processes from the ground up.
• Competitive salary and benefits package.
• Career growth opportunities in a high-impact role.

Join us at Crypto Finance Group, where everyone can make a significant impact. We invite you to be part of our journey and help shape the future of our company.

About Crypto Finance

Crypto Finance Group, part of Deutsche Börse Group, provides professional digital asset solutions to institutional clients. The Group comprises of Crypto Finance AG, regulated by FINMA in Switzerland, which offers trading, custody, and wallet services, as well as Crypto Finance (Deutschland) GmbH, regulated by BaFin in Germany, which offers trading and custody.

For more information, please visit our website at

Key Responsibilities

• Take on a key role in the QA team that tests, supports, and coordinates the correct execution of our custom-built order management, infrastructure, and risk tools with client-facing and internal components in an agile development environment.

• Contribute to both manual and automated testing efforts. Take part in specifications and engineering requirements.

• Manage release process, executing manual tests, reviewing automated and manual test outcomes, analyzing performance test results, scrutinizing logs for anomalies, and reporting on the quality of the release candidate.
• Process product reviews, and inform the development team of defects and errors, and also communicate quantitative and qualitative findings from test results to the development team. Monitor efforts to resolve product issues and track progress.
• Ensure that the final product satisfies the product requirements and meets end-user expectations. Spot areas for improvement to enhance the product's efficiency.

• Excellent interpersonal and communication skills, strong work ethics, eye for detail, patience, and strong documentation abilities
• Completed technical degree
• Experience designing test plans and writing test case scenarios
• Experience with test management tools, such as TestRail, Zephyr, etc.
• Experience working within the Agile framework
• Must have a product-oriented mindset, be creative and take the initiative to improve product test coverage and effectiveness
• Experience working with tools such as Jira, Confluence, etc.
• Relevant training and/or certification, such as ISTQB is an advantage

Nice to have

• Familiarity with UI automation tools like Selenium, Cypress, Playwright, etc.
• Familiarity with industry trends, the latest frameworks, and the trade-offs of existing automation/testing solutions
• Experience in a programming language (preferably Python)

• Become a part of a leading company in the crypto asset space
• Great company culture within an established and renowned group
• Gain deep insights into crypto asset trading, market making, execution strategies, settlement, and custody, etc.

• Work in an exciting, fast-paced, and expanding industry with opportunities and a range of topics that go beyond the traditional financial industry

• Team-oriented and entrepreneurial mindset with high ethical standards

Culture

• At the heart of our company, we prioritise:
• Innovation and Continuous Learning
• Collaboration and Knowledge Sharing
• Entrepreneurial Spirit and Flat Hierarchies
• Values such as Excellence, Delivery, Ownership, Passion, and Unity

Please note:

• We do not accept CVs from recruiting or staffing agencies
• Due to Swiss labour legislation, we can only accept applicants who have the right to work in Switzerland (are in possession of a Swiss work permit or are EU/EFTA citizens). All other applications will not be considered.

Viatris Pharma GmbH

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:

Access – Providing high quality trusted medicines regardless of geography or circumstance;

Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and

Partnership – Leveraging our collective expertise to connect people to products and services.

Unser globales Portfolio umfasst erstklassige, ikonische Markenprodukte sowie globale Schlüsselmarken; Generika, einschließlich Marken- und komplexer Generika; und andere Angebote in einem breiten Spektrum therapeutischer Bereiche. Wir setzen uns dafür ein, weltweit gesündere Gemeinschaften durch Bildung, Aufklärung und besseren Zugang zu Behandlungsmöglichkeiten zu schaffen.

Den Mitarbeitern, die bestrebt sind, ihr Leben mit Ziel zu leben hilft Viatris ihr volles Potenzial auszuschöpfen, indem eine kollaborative Kultur geschaffen wird die Mut und Widerstandsfähigkeit fördert. Viatris ist mehr als nur ein Arbeitsplatz. Dies ist ein Ort, an dem man einen Unterschied in der Welt machen kann.

Ihre Rolle

In dieser spannenden Position übernehmen Sie Verantwortung als Quality Assurance Manager. Sie stellen sicher, dass unsere Produkte höchsten Qualitätsstandards entsprechen – von der Herstellung bis zur Auslieferung – und leisten so einen direkten Beitrag zur Gesundheit von Patient:innen.

Ihre Aufgaben:

• Überwachung der Compliance für die Schweizer Niederlassung zur Sicherstellung der Einhaltung von cGMP/cGDP-Vorgaben, regulatorischen Anforderungen, Branchenstandards, globalen Richtlinien und lokalen Prozessen.
• Unterstützung bei der Erstellung von Chargendokumentationen, Bewertung und Freigabe von Produktchargen für den Schweizer und Liechtensteiner Markt unter Einhaltung der Qualitätsanforderungen gemäß Schweizer Vorschriften.
• Identifikation und Umsetzung von kontinuierlichen Verbesserungsmöglichkeiten im Verantwortungsbereich sowie Einleitung von Korrekturmaßnahmen zur Steigerung der Gesamtqualität.
• Fähigkeit zur effektiven Zusammenarbeit und Kommunikation in einer Matrixorganisation.
• Unterstützende Funktion bei qualitätsbezogenen Verbesserungsprojekten.
• Unterstützende Funktion bei der Bearbeitung von Produktrücksendungen, CQNs, PMSI, Abweichungen, CAPA, Change Control, Lieferantenqualifizierung und PQR-Management.
• Unterstützung bei Behördeninspektionen.
• Durchführung von Schulungen zu Qualitätsverfahren, regulatorischen Anforderungen und Best Practices gemäß Verantwortungsmatrix zur Sicherstellung eines informierten und regelkonformen Teams.

Ihr Profil:

Sie sind eine engagierte Persönlichkeit mit hoher Eigenverantwortung und Qualitätsbewusstsein und bringen folgendes mit:

• Hochschulabschluss in Pharmazie oder Naturwissenschaften (PhD von Vorteil)
• Mindestens 5 Jahre Erfahrung im pharmazeutischen Qualitätswesen
• Sehr gute Kenntnisse der regulatorischen Anforderungen (TPA, MPLO, GMP, GDP)
• Erfahrung im Umgang mit Behörden und Audits
• Analytisches Denken, Entscheidungsstärke und Genauigkeit
• Verhandlungssichere Englischkenntnisse, Deutsch (Französisch von Vorteil)
• Zertifizierung als interner Auditor ist ein Plus

Was wir bieten

• Ein Great Place to Work-zertifiziertes Umfeld mit motiviertem Teamspirit
• Karriere- und Entwicklungsmöglichkeiten in einem internationalen Pharmaunternehmen
• Attraktive Work-Life-Balance-Initiativen und flexible Arbeitsmodelle

Bei Viatris sind wir bestrebt einen wirklich vielfältigen, integrativen und authentischen Arbeitsplatz zu schaffen. Wenn Sie also von dieser Rolle begeistert sind, Ihre bisherigen Erfahrungen jedoch nicht vollständig mit allen Anforderungen übereinstimmen, ermutigen wir Sie trotzdem sich zu bewerben. Möglicherweise sind Sie genau der/die richtige Kandidat:in für diese oder andere Rolle.

Warum Viatris?

Bei Viatris bieten wir wettbewerbsfähige Gehälter, Sozialleistungen und ein inklusives Umfeld, in dem Sie Ihre Erfahrungen, Perspektiven und Fähigkeiten nutzen können, um das Leben anderer zu beeinflussen. Sie werden auch die Möglichkeit haben hervorragende Karrierechancen und Initiativen zur Vereinbarkeit von Berufs- und Privatleben zu nutzen.

Vielfalt & Inklusion bei Viatris

Bei Viatris sind Vielfalt und Inklusion wesentliche Bestandteile unserer Mission. Die Vielfalt, die wir in allen Bereichen unseres Geschäfts fördern, kann eine unserer größten Stärken sein, wenn es darum geht das Gesundheitswesen nicht so zu definieren, wie es ist, sondern wie es sein sollte. Wenn Sie mehr darüber erfahren möchten, was Vielfalt, Gerechtigkeit und Inklusion für uns bedeuten besuchen Sie bitte

Nachhaltigkeit bei Viatris

Soziale Unternehmensverantwortung ist ein grundlegender Bestandteil der Mission von Viatris. Wir arbeiten daran, verantwortungsbewusste und nachhaltige Betriebsabläufe voranzutreiben und nutzen unser kollektives Fachwissen, um Menschen in jeder Lebensphase zu einem gesünderen Leben zu verhelfen, da wir erkennen, dass unsere Handlungen die Interessengruppen und Gemeinschaften, denen wir dienen, beeinflussen. Um mehr über unsere Bemühungen zu erfahren, besuchen Sie bitte

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.

Job Description
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Specialist, Quality Operations Schachen reports to the Associate Director, QA Operations and Compliance Biologics and supports clinical quality activities at our Werthenstein site. The successful candidate will have accountability for Good Manufacturing Practice (GMP) compliance, ensuring clinical supply functions operate within GMP requirements and compliant clinical drug substance and drug product supply. The candidate will drive or support compliance-based programs and results which include support and/or leading cross functional projects, solving complex problems, current Good Manufacturing Practices (cGMP) quality initiatives, quality system improvements, quality directives, compliance metrics and monitoring, Standard Operating Procedure (SOP) management, and site procedures.

Responsibilities

• Apply critical decision making, project management skills.
• Participate in the release or rejection of GMP materials and components either through direct batch release support or involvement with critical program issues.
• Provide guidance, consulting, interpretation of GMP and regulatory requirements or standards.
• Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality systems, regulatory, etc. at all levels.
• Ensure deviations are investigated and resolved (within quality as well as functional areas). Lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions.
• Support, review and approve as needed the change management program (Change Control).
• Provide guidance and support on equipment qualification, System Development Life Cycle (SDLC), activities, environmental monitoring, as well as support of utilities functions.
• Perform SOP review and approval within Quality and for functional area procedures.
• Conduct all work meeting high standards for quantity, integrity, quality, and GMP compliance.

Your Profile

• A Master's Degree in Engineering, Sciences or related field and at least five (5) years of experience in the pharmaceutical, biotech or another regulated industry.
• Experience with formal problem-solving techniques and a hands-on approach to problem solving, such as Root Cause Analysis and/or Lean Six Sigma tools
• cGMP experience in a sterile, vaccine, bulk or finished goods pharmaceutical environment.
• Detailed understanding of Critical Process Parameters, Critical Quality Attributes and general principles of equipment qualification.
• Experience and in-depth knowledge of fully integrated, automated and recipe driven operation e.g. DeltaV, SAP, MES.
• Experience in drug product filling and inspection practices.
• Fluent in English and German a plus.
• Experience in pharmaceutical, biotech or other regulated industry.
• Technical writing experience, i.e. investigations, laboratory reports, standard operating procedures, batch records, or protocols.
• Ability to conduct multiple investigations within established deadlines.
• Demonstrated ability to manage multiple projects and initiatives.

The Company
Our Company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been established in Zurich, aimed at accelerating the development and commercialization of many of our company's medicines and vaccines, which supports our mission to save and improve lives around the world.

We are proud to be certified as a "Top Employer Switzerland" and "Top Employer Europe" showing the company's commitment to our employees and the community around us.

Our Werthenstein BioPharma site in Schachen is where we conduct cutting-edge research, develop and analyze new biological agents, produce new products and supply clinical trial products for global clinical studies. The site is also home to one of our global forensic laboratories where we carefully monitor our products through the supply chain to ensure security and safety for our patients.

Who We Are …
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What We Look For …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status
Regular

Relocation:
No relocation

VISA Sponsorship
No

Travel Requirements
10%

Flexible Work Arrangements
Not Applicable

Shift
Not Indicated

Valid Driving License
No

Hazardous Material(s)
N/A

Required Skills
Auditing, Auditing, Change Management, Compliance Monitoring, Compliance Reporting, Data Analysis, Detail-Oriented, GMP Compliance, Good Manufacturing Practices (GMP), Investigation Management, IS Audit, Lean Six Sigma (LSS), Legal Document Review, Manufacturing Operations, People Management, Pharmaceutical Industry, Policy Implementation, Problem Solving, Process Improvements, Quality Assurance (QA), Quality Assurance Systems, Quality Metrics, Regulatory Compliance, Standard Operating Procedure (SOP), Standard Operating Procedure (SOP) Management {+ 4 more}

Preferred Skills
Batch Record Review, Change Controls, Master Batch Records, Six Sigma

Job Posting End Date
09/10/2025

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:
R

Quality Assurance Manager

Location:
Basel, Switzerland

Type:
Permanent

We are currently seeking a Quality Assurance Manager to join a global healthcare company that is redefining access to medicine. With a diverse portfolio that includes branded products, generics, and complex therapies across multiple therapeutic areas, the organization is committed to enhancing patient health at every stage of life.

This is an opportunity to be part of a mission-driven company that combines innovation, sustainability, and global reach to make healthcare more accessible and equitable. If you're passionate about quality, compliance, and continuous improvement, this is your opportunity to contribute to a team that's shaping the future of healthcare.

What You'll Do:

• Ensure compliance with cGMP/cGDP and regulatory standards
• Support batch documentation and product release for Swiss and Liechtenstein markets
• Drive continuous improvement initiatives and corrective actions
• Contribute to quality-related projects and regulatory inspections
• Deliver training on quality procedures and best practices

Role Requirements:

• University degree in pharmacy or natural sciences (PhD an advantage)
• At least 5 years of experience in pharmaceutical quality assurance
• Very good knowledge of regulatory requirements (TPA, MPLO, GMP, GDP)
• Experience in dealing with authorities and audits
• Analytical thinking, decision-making skills and accuracy
• Fluent in English and German (French is an advantage)
• Certification as an internal auditor is a plus

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Specialist, Quality Operations Schachen reports to the Associate Director, QA Operations and Compliance Biologics and supports clinical quality activities at our Werthenstein site. The successful candidate will have accountability for Good Manufacturing Practice (GMP) compliance, ensuring clinical supply functions operate within GMP requirements and compliant clinical drug substance and drug product supply. The candidate will drive or support compliance-based programs and results which include support and/or leading cross functional projects, solving complex problems, current Good Manufacturing Practices (cGMP) quality initiatives, quality system improvements, quality directives, compliance metrics and monitoring, Standard Operating Procedure (SOP) management, and site procedures.

Responsibilities:

• Apply critical decision making, project management skills.
• Participate in the release or rejection of GMP materials and components either through direct batch release support or involvement with critical program issues.
• Provide guidance, consulting, interpretation of GMP and regulatory requirements or standards.
• Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality systems, regulatory, etc. at all levels.
• Ensure deviations are investigated and resolved (within quality as well as functional areas). Lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions.
• Support, review and approve as needed the change management program (Change Control).
• Provide guidance and support on equipment qualification, System Development Life Cycle (SDLC), activities, environmental monitoring, as well as support of utilities functions.
• Perform SOP review and approval within Quality and for functional area procedures.
• Conduct all work meeting high standards for quantity, integrity, quality, and GMP compliance.

Your Profile:

• A Master's Degree in Engineering, Sciences or related field and at least five (5) years of experience in the pharmaceutical, biotech or another regulated industry.
• Experience with formal problem-solving techniques and a hands-on approach to problem solving, such as Root Cause Analysis and/or Lean Six Sigma tools
• cGMP experience in a sterile, vaccine, bulk or finished goods pharmaceutical environment.
• Detailed understanding of Critical Process Parameters, Critical Quality Attributes and general principles of equipment qualification.
• Experience and in-depth knowledge of fully integrated, automated and recipe driven operation e.g. DeltaV, SAP, MES.
• Experience in drug product filling and inspection practices.
• Fluent in English and German a plus.
• Experience in pharmaceutical, biotech or other regulated industry.
• Technical writing experience, i.e. investigations, laboratory reports, standard operating procedures, batch records, or protocols.
• Ability to conduct multiple investigations within established deadlines.
• Demonstrated ability to manage multiple projects and initiatives.

THE COMPANY

Our Company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been established in Zurich, aimed at accelerating the development and commercialization of many of our company's medicines and vaccines, which supports our mission to save and improve lives around the world.

We are proud to be certified as a "Top Employer Switzerland" and "Top Employer Europe" showing the company's commitment to our employees and the community around us.

Our Werthenstein BioPharma site in Schachen is where we conduct cutting-edge research, develop and analyze new biological agents, produce new products and supply clinical trial products for global clinical studies. The site is also home to one of our global forensic laboratories where we carefully monitor our products through the supply chain to ensure security and safety for our patients.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Required Skills:

Auditing, Auditing, Change Management, Compliance Monitoring, Compliance Reporting, Data Analysis, Detail-Oriented, GMP Compliance, Good Manufacturing Practices (GMP), Investigation Management, IS Audit, Lean Six Sigma (LSS), Legal Document Review, Manufacturing Operations, People Management, Pharmaceutical Industry, Policy Implementation, Problem Solving, Process Improvements, Quality Assurance (QA), Quality Assurance Systems, Quality Metrics, Regulatory Compliance, Standard Operating Procedure (SOP), Standard Operating Procedure (SOP) Management {+ 4 more}

Preferred Skills:

Batch Record Review, Change Controls, Master Batch Records, Six Sigma

Job Posting End Date:

09/10/2025

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R

MyLife Diabetes Care AG is a new, independent medtech company specialising in the treatment of diabetes using advanced insulin pump systems. To strengthen our Quality Management department, we are looking for a very experienced and custom oriented person for our Diabetes Care Business in the B2C sector for our new Headquarter in Burgdorf.

Ref. No. 7828

Location:
Burgdorf | Hybrid

Help us bring to market state-of-the-art medical technology solutions by optimizing processes and ensuring quality through your structured approach.

• Prepare, support the creation and review and execute the release of all technical documentation for digital health and software products ensuring compliance with applicable standards and regulatory requirements such as IEC 62304, IEC 82304-1
• Ensure regulatory compliance of digital health technologies, including cloud platforms, software development kits for mobile applications (SDKs), embedded software, and mobile applications
• Ensure effective change control activities during the entire product life cycle
• Ensure validation of tools and computer systems in compliance with ISO 80002-2 and AAMI TIR36, maintaining appropriate documentation and traceability
• Ensure compliance with interoperability regulations and standards by overseeing documentation, risk management, and quality assurance activities related to software interfaces, following ANSI/AAMI/UL 2800 series
• Work independently and support the teams in Burgdorf/Switzerland and Barcelona/Spain
• Ensure that secure software development practices are linked to risk management activities and reflected in the product documentation
• Support the documentation of data protection and electronic records compliance (GDPR, HIPAA, 21 CFR Part 11) throughout the product lifecycle.
• Support and strengthen software risk management activities by ensuring full traceability and alignment between ISO 14971 and IEC 62304 requirements, emphasizing continuous risk evaluation throughout the lifecycle

• Bachelor’s degree in computer science, software engineering or another relevant scientific discipline, or equivalent combination of education and years of applicable experience
• 5 years of professional experience in software quality assurance or regulatory affairs related to medical devices, with a focus on software as a medical device (SaMD) preferred
• Experience in the implementation of the process and tools to develop software according to IEC 62304
• Experience with software validation, cybersecurity, data protection and artificial intelligence
• Proven experience in preparing and submitting regulatory filings, managing regulatory interactions, and facilitating successful product approvals
• Outstanding communication skills, with the ability to collaborate effectively with cross-functional teams
• In-depth knowledge of quality management systems (QMS) standards (e.G., ISO 13485 and MDSAP), medical device regulations (e.G. FDA, EU MDR, UK MDR, Health Canada), and software development lifecycle methodologies
• Strong understanding of risk management principles, design controls, verification and validation processes, post-market surveillance and vigilance requirements for medical devices including software development standards (e.G. IEC 62304, IEC 62366)
• Written and spoken English

Bei mylife Diabetes Care entwickeln wir integrierte Lösungen, auf die sich Menschen mit Diabetes wirklich verlassen können.
Wir sind ein schnell wachsendes, familiengeführtes Unternehmen mit Hauptsitz in Burgdorf (CH) – gegründet auf 40 Jahren Innovation und international tätig.
Wir vereinen Fachkompetenz, Engagement und eine klare Mission: Menschen durch bessere Kontrolle mehr Freiheit zu ermöglichen.
Alles, was wir tun, entsteht mit Sinn und wird mit Sorgfalt gestaltet.
Unsere Kernkompetenz liegt in der automatisierten Insulindosierung (AID). Mit mylife Loop bieten wir ein AID-System, das sich den individuellen Bedürfnissen und dem Alltag von Menschen mit Diabetes anpasst.

Marcel Brader
Human Resources Expert Recruiting

+41 (0)

Burgdorf

Ort: Visp (Schweiz)

Bei Bedarf steht für berechtigte Kandidaten und ihre Familien Unterstützung beim Umzug zur Verfügung.

Lonza ist heute ein weltweit führendes Unternehmen im Bereich Life Sciences, welches auf drei Kontinenten tätig ist. Wir sind in der Wissenschaft tätig, jedoch gibt es keine Zauberformel dafür, wie wir die Arbeit angehen. Unsere wichtigste wissenschaftliche Lösung sind talentierte Mitarbeitende, die zusammenarbeiten und Ideen entwickeln, die anderen Unternehmen helfen, Menschen zu helfen. Im Gegenzug steuern unsere Mitarbeitenden ihre Karriere selbstständig. Denn ihre Ideen, ob gross und klein, verbessern die Welt. Und das ist die Art von Arbeit, an der wir Teil haben möchten!

Werden Sie Teil unseres QC 24/7 Analytical Services Teams – die zentrale Drehscheibe für innovative Analysen in der Biologics-Produktion am Standort Visp!

Unser Team ist der erste Anlaufpunkt für sämtliche analytischen Proben aus der Produktion – und das rund um die Uhr. Mit Präzision und Fachwissen aliquotieren wir Proben gemäß Vorschriften, bereiten sie für die Weiterverarbeitung vor und führen zeitkritische Analysen durch, die essenziell für den Erfolg aller Technologien sind. Ob Chromatographie, Biochemie, Mikrobiologie oder Physikalische Chemie – wir meistern die ganze Bandbreite.

Was macht diese Rolle so spannend?
Als Analyst in unserem QC 24/7 Analytical Services Team haben Sie die Wahl: Entweder spezialisieren Sie sich auf eine der hochmodernen Technologien oder Sie erweitern Ihr Know-how über unser umfassendes Portfolio an analytischen Tests. Hierzu zählen z. B.:

• Bioburden- und Endotoxinbestimmungen

• Chromatographische Methoden wie SEC und HPLC

• ELISA, UV, TOC, pH und vieles mehr

Tauchen Sie ein in eine dynamische, technologiegetriebene Umgebung, in der keine Probe wie die andere ist, und gestalten Sie den Fortschritt mit!

Was wir Ihnen bieten:

• Während des Trainings und der Einarbeitungszeit stehen Ihnen erfahrene Mitarbeiter zur Seite, zum schnellen Erwerb aller evtl. fehlenden Kenntnisse oder Erfahrungen

• Umzugsunterstützung steht berechtigen Kandidaten und ihren Familien bei Bedarf zur Verfügung.

• Weiterbildungs- und Aufstiegsmöglichkeiten je nach individuellem Schwerpunkt Ihrer Fähigkeiten (e.g. Ausbildung zum Trainer einer Technologie)

• Leere Skihänge oder Wanderwege wenn Sie unter der Woche frei haben dank des 4-Schicht-Betriebs

Ihre Aufgaben:

• Aliquotieren von Proben unter aseptischen Bedingungen

• Durchführung und Dokumentation von zeitkritischen IPC-Analysen (Bioburden, Endotoxine, HPLC, TOC, UV, pH, usw.)

• Alle Tätigkeiten werden unter Einhaltung der GMP Richtlinien ausgeführt

• Arbeiten mit hochaktiven Wirkstoffen (AHSK 4/5)

Ihr Anforderungsprofil:

• Abgeschlossene Berufsausbildung (Naturwissenschaftlich-technisches Fachgebiet wie pharmazeutische Technologie, Biotechnologie, Chemie, Verfahrenstechnik bevorzugt)

• GMP Kenntnisse sind ein Plus

• Hohe Lern– und Einsatzbereitschaft sowie Flexibilität

• Sicherheits- detail- und pflichtbewusstes Arbeiten

• Sehr gutes Verständnis von technischen Zusammenhängen

• Verhandlungssichere Deutschkenntnisse, Englischkenntnisse sind ein Plus

• Bereitschaft zur Schichtarbeit (4-Schicht-Betrieb)

Lonza’s Produkte und Services wirken sich täglich positiv auf Millionen von Menschen aus. Für uns stellt dies nicht nur eine grosse Ehre, sondern auch eine grosse Verantwortung, dar. Wie wir unsere Geschäftsergebnisse erreichen ist für uns genauso wichtig wie unsere Erfolge selbst. Bei Lonza wird Respekt grossgeschrieben und wir schützen sowohl unsere Mitarbeiter als auch unsere Umwelt. Erfolg für uns bedeutet moralisch vertretbarer Fortschritt.

Zu Lonza kommen Menschen, die Herausforderungen annehmen und mit ihrer Kreativität im Bereich

Life Science neue Ideen für komplexe Problemstellungen entwickeln. Zusammen leisten wir einen Beitrag, der das Leben vieler Menschen auf der ganzen Welt verbessern kann. Dies bietet ihnen die Gewissheit und die Zufriedenheit, mit der eigenen Arbeit wirklich einen Unterschied zu machen.