P2325 - Global (Senior) Manager, Procedural Document & Training Quality Lead
Jobbeschreibung
Lausanne, Waadt, Schweiz
Debiopharm
19.05.2024
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DescriptionDebiopharm is an independent biopharmaceutical company
based in Switzerland with an ongoing commitment to research in
oncology and infectious diseases in order to improve patient outcomes
and quality of life. Our main activities include drug development,
drug manufacturing and digital health investment. Debiopharm
International SA aims to develop innovative therapies that target high
unmet medical needs. Our unique “development only” business model
allows us to act as a bridge between disruptive discovery products and
patient access in international markets. We first identify
high-potential compounds for in-licensing, clinically demonstrate
their safety and efficacy and then select large pharmaceutical
commercialization partners to maximize patient access globally.At
Debiopharm you will be at the forefront of the fight against cancer
and infectious diseases, and you will have the opportunity to work on
new innovative medicines for patients. Efficiency is our mode of
action, saving lives our collective target.Here: For our Quality
Management organization based at our Headquarters in Lausanne, we are
looking for aGlobal (Senior) Manager, Procedural Document & Training
Quality LeadIn this role, you will drive the overall management of
Procedural Document Management and Training Management activities
throughout the Debiopharm International SA (DPI) organization. You
will build a collaborative working relationship & partner with the
business partners and cross-functional Quality Peers. This role
requires active participation to Regulatory Authority Inspections &
Due Diligence Activities.Your responsibilities will be but not limited
to:Procedural Document ManagementEvaluate, design, optimize &
implement the DPI Procedural Document (ProcDoc) Strategy in alignment
with business objectivesPartner with critical quality & business
representatives to drive the newly Quality Management System (QMS)
module, more specifically Procedural Document Management SystemPartner
with Process Owners to design & implement well-defined process,
ensuring integration of people, process and system components in
business critical ProcDocsIn collaboration with the business
representatives, contribute to cross-functional process development &
improvement initiativesAct as a change agent supporting compliance and
continuous improvement of critical business processesEvaluate, design,
optimize, implement the DPI Training & Learning Strategy and System in
alignment with business objectivesPartner with critical quality &
business representatives to drive the set up and implementation of the
newly QMS module, more specifically Learning Management
SystemEstablish and drive an effective role-specific learning and
development structure and “just in time knowledge management” to
enable the desired business resultsPartner with Department Heads to
ensure fit-for-purpose role-based training curricula are in
placeIdentify, evaluate, assess, and select external training vendors
ensuring effective availability of effective training programs on
specific topicsAct as a change agent supporting compliance and
continuous improvement of DPI training activities in view of
on-boarding and continuous learning.Work with the Quality Leads to
create and execute on engaging eLearning, instructor-led learning,
virtual instructor-led learning based on experience from audit,
inspection, CAPA and other sourcesEnsure proper CAPA & KPI are
developed and monitored Training / Learning
managementRequirementsMaster’s degree in a scientific discipline or
equivalent combination of education and experiencePreferably 15 years’
experience in the Pharmaceutical or Biotechnology industry with a
solid experience of at least 8-10 years in QMS in a GxP environment
Solid experience and expertise in design, harmonization,
implementation, and optimization of cross-functional end-to-end
business processes Six Sigma certification/operational excellence
and/or experience with process mapping tools and systems is
desirableExperience in understanding global regulatory GxP
requirements and industry trends with the ability to apply them to
process improvementExperience in supporting Regulatory Inspection and
Due Diligence activitiesSignificant experience with QMS tools, more
specifically Procedural Document Management System and Learning
Management SystemFunctional planning experience & ability to develop
functional vision, priorities and tacticsStrong leadership, pragmatic
collaboration and influencing skills in a complex, matrix
environmentExperience in mentoring, coaching and directing people to
ensure proper implementation of the management endorsed strategyStrong
team player, with excellent interpersonal communication skills Used to
simultaneously support multiple projects, duties and assignments and
prioritize accordinglySelf-dependent way of working; taking ownership
of assigned tasks; plan and deliver according to agreed
timelinesProficiency in English (C1 Oral & written), fluent French is
an assetBenefitsDebiopharm offers employees:International, highly
dynamic environment with a long term vision.Cross-functional
collaboration at the forefront of the most advanced scientific
developments in oncology and anti-bacterial industryExposure to a wide
variety of areas and functions within clinical development and the
pharmaceutical industryParticipation in a company where innovation,
people and entrepreneurship are the fundamental keys to success.Proud
to be an Equal-Pay certified, we ensure offering to all our employees
the same opportunities The use of external staffing agencies or
recruiters requires prior approval from our Human Resources
Department. The Human Resources Department at Debiopharm requests
external staffing agencies or recruiters not to contact Debiopharm
employees or members of the Board of Directors directly in an attempt
to present candidates.Submission of unsolicited resumes in advance of
an agreement between the Human Resources Department and the external
staffing agency or recruiter does not create any implied obligation on
the part of Debiopharm.Debiopharm will not accept unsolicited resumes
from any source other than candidates themselves for either current or
future positions.Job SummaryID: 4EC129DCBDDepartment: QualityType:
full time
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p2325 - Global (Senior) Manager, Procedural Document & Training Quality Lead
Debiopharm
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