Sr. Manager, Tpq Clinical Manufacturing - Rixensart, België - GSK

GSK
GSK
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Rixensart, België

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Sophie Dubois

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Sophie Dubois

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Beschrijving

Site Name:
Belgium-Rixensart


Posted Date:
Jul


_ About the role_:


As a senior Manager, you will be responsible for designing, developing and implementing Third-Party Quality strategies and quality oversight for external GMP/GDP services provided to GSK Vaccines R&D in order to ensure that GSK external providers of critical services (seeds/cell banks, drug substance, adjuvants, drug products manufacturing and testing, IMP packaging and storage/distribution) comply with GSK data integrity and quality standards, GxP regulations and meet national health authority requirements.


You will promote and implement a Quality and Safety culture within Vaccines R&D, including Technical R&D; and provide GSK business owners and third parties with GMP expertise and regulatory compliance advisory and act as a valuable source to TRD GMP and GSK R&D Clinical Supply Chain for the selection of GMP suppliers for vaccine R&D projects allocated, while promoting operational efficiency, continuous improvement and contributing to vaccine pipeline progression.


_ About the responsibilities_:


  • Responsible for the design, development, and deployment of Quality strategies for GMP/GDP third parties supporting Vx TRD for Vaccine R&D projects, including for externalized process/product developments outsourced to CDMOs.
  • Drive and support the business by implementing endtoend quality oversight of GMP third parties in scope (this includes, but not only: make the initial technical assessment of external providers, assess third parties and quality risk management; lead, negotiate, review and implement Quality Clauses/Agreements with business partners and third parties in scope and/or across R&D, including GSK Pharma R&D for vendors in common, to ensure compliance with current regulations, GSK quality standards associated with the activities to be carried out by the third party; track, analyze, and communicate metrics to ensure efforts are implemented effectively and in line with quality goals, strategy, and objectives; identify improvement opportunities; Lead and perform a periodic Risk assessment regarding the Third Party, he/she is responsible for; identify, assess and mitigate quality risks adequately; develop and maintain the inscope audit universe and propose a fitforpurpose strategy for the yearly TP audit planning, per business needs and requirements).
  • Interface with R&D Procurement, Legal, Auditing Teams, and business partners including GSK Corporate and Pharma R&D to ensure internal GSK alignement on third party quality oversight, while remaining independent in his/her quality evaluation role. Interact with the Technical Development Lead and CMCQ to ensure all product and processrelated issues are properly addressed at the Third Party.
  • Review and approve all the required documentation for the batch release process and contribute to the GMP Third Parties release certification (batch review delegation to TP) and reassessment process; support auditreadiness status maintenance, preparation, conduct, and followup for Audit & Inspection activities, when appropriate, in direct interaction with the Vx Quality for R&D audit team.
  • Escalate, manage and support issues management. Engage with third parties on operational issues (e.g. process deviations, outofspecifications QC results) that require an investigation by the vendor, to fully assess Product Quality impact and inform batch(es) usage decision.
  • Contribute to the development, improvement & simplification of standards and processes across the Q4R&D Third Party department, specifically within TPQ, and in the context of the R&D QMS implementation.
  • Remain current with industry trends and changes in the regulatory and external environment through established networks to ensure that any issues likely to impact the Third Party network are well understood and communicated to avoid disruption to services.
  • Promote partnering with peers and strong interactions between GSK Vaccines R&D and Pharma R&D, and utilize its expertise to influence, simplify and provide insightful analysis to align ways of working and achieve improvement of common processes and help the Q4R&D department to optimize oversight and risk assessment of Third Parties.

_ About you _:


  • Bachelor's degree in Life Sciences, and 1015 years of experience in the pharmaceutical industry
  • Excellent knowledge in cGMP, including EU and US regulations, ICH/ISO guidelines and requirements.
  • Experience in early and/or latestage development and associated scientific practices and regulation.
  • Demonstrated knowledge of inspection management, and industry quality assurance practices and systems
  • Experience in planning and executing supplier audits to identify, manage, correct and reduce significant risks/noncompliances, audit techniques, including listening and interviewing skills
  • Experience in quality systems and manufacture and release of APIs/Drug Substances, Drug Products and pac
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