Sr. Specialist, QA Documentation-Training & Quality Systems

Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.Position: Sr. Specialist, QA Documentation-Training & Quality SystemsSupervisor: Associate Director, QS & CompliancePrerequisites: BS in Science or related field. + minimum of 5 years experience in a pharmaceutical company or other related industry, ideally in Quality Assurance.CompetencesThis position is within the Global Internal Manufacturing Quality Operations organization, reporting to the Associate director Quality Systems (QS) & Compliance.As part of the QA Documentation & Training team, the Sr. Specialist is responsible to support the Quality Document Management System for BMS Internal Manufacturing Boudry as well as some associated organisation.Moreover, the position holder will support the GMP/GDP Training system, including the maintenance of the LMS for the above listed locations.Additionally, the Sr. Specialist will actively support Celgene/BMS Boudry manufacturing site and other departments to ensure cGMP compliant processes with regards to Quality Systems.The activities include the participation in at least following processes: self-inspections and internal audits, health authority inspections, annual product review reporting, deviations, change and risk management.Skills/Knowledge RequiredAt least 5 years of experience in a pharmaceutical company or other related industry, ideally in Quality AssuranceBS in Science or related field.Experience in handing of controlled Quality Documentation & Training in a regulated environmentFluent in French, working knowledge in English (B2)Very good understanding of cGMPs and regulatory requirementsExcellent interpersonal and collaborative skillsGood organization skills and priority managementWorks independently on routine tasks, makes decisions for minor issuesComfortable providing training / guidance to systems users as neededAbility to focus attention to detailsExcellent problem-solving skillsDrives continuous improvement and “out of the box” thinkingGood communication and ability to work in multicultural and evolving environmentKnowledge of most common office software (Microsoft Office)Duties and ResponsibilitiesDocumentation management: Ensure Quality Documentation complies with established BMS Electronic Documentation Management System procedures & policies.Act as QA Documentation reviewer and approver within the Document Lifecycle Management workflow.Provide timely and efficient support to the EDMS & LMS users in handling document workflows, training assessment and document change request.Monitor progress of documents in workflows, ensure timely follow up and completionMonitor the Periodic Review Process of documents.Print / issue document controlled copies and logbooks and ensure their controlled distribution in collaboration with requesting department.Training management:Work in close collaboration with hiring managers to collect and complete on-boarding activities for new employees/contractors.Provide New Employee Orientation training to new hires in French and English.Responsible for the creation and assignment of GMP/GDP training in BMS electronic Learning Management system (Success Factors).Create, update and assign Personnel Training profiles and curriculum in accordance with Training management request.Coordinate the creation and update of curricula and their respective users assignment.Support the deployment and execution of GMP training intended for all Boudry manufacturing sites departments involving GMP activities.Archive management: Ensure Documentation & Records are archived, retained and destructed in compliance with BMS retention requirements (storage, retrieval for consultation, destruction).Provide support and guidance to document owners / departments for documents and records archiving process.Complete physical & electronic archiving process, as well as archives externalization.Improve the Archives access process and associated controls and documentation.Compliance: Write the annual product reports for products made at the Boudry internal manufacturing site.Contribute to the preparation and execution of authorities inspections and corporate audits in different roles (i.e. back office, subject matter expert, note taker or runner) for Boudry.Support internal audits and health authority inspections by providing all requested documentation and systems extracts timely.Coordinate data collection and support response to regulatory authorities requests e.g. in the scope of submission or periodic GMP review.Contribute to regular reporting of quality processes metrics for different review meetings and provide improvement ideas.Assist with writing SOPs and makes recommendations for SOP revisions for the Quality Operations and supported departments of Boudry internal manufacturing site.In additionAct as Administrator and Super User of the electronic Documentation Management System & LMS Success Factors.Assist with the development / writing / continuous improvement of procedures in relation with document management, archiving system and LMS system.Act as an action owner in case of initiated actions as a response to deviations, audits or inspections.Be involved in the quality systems processes and take over some responsibilities with regards to deviation and/or change control management.Act as deputy for colleagues within QS & Compliance team.Definitions and AbbreviationscGMP/GMP:     Current Good Manufacturing PracticesDMS:   Documentation Management SystemGDP:                Good Distribution PracticesLMS:                Learning Management SystemQA:            Quality AssuranceSOP:                Standard Operating ProcedureIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as “Transforming patients’ lives through science ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.