Job Code: YX05-22
The Biotherapeutics Development Unit at Novartis is seeking a senior Quality Assurance leader responsible for the efficient operation of all quality aspects (cGMP/cGLP/cGCP) for the unit in accordance with the Novartis Quality System requirements, ensuring high product quality, regulatory compliance and operational efficiency. The incumbent will work directly with the discovery and development project/program teams to develop Quality strategy and provide guidance for biologics drug development, including senior level input in support of preclinical/early/full development, registration and approval/post-approval activities. The incumbent will have quality oversight of several programs including development of quality strategy, preparation of the Health Authority submissions, and collaboration with internal and external partners for inspections under the strategic leadership of the senior management of Novartis Group Quality and Biologics Quality in Pharma Development (see details below as QA project leader / QA manager and Analytical expert) . The incumbent will also evaluate in-licensing opportunities and carry out Due Diligence activities as required.
Scientific degree from accredited Technical University, preferably in Microbiology, Chemistry or Pharmacy; Ph.D. preferred.
Languages: Fluent English (oral and written), other languages are a plus.
• At least 10 years experience in Quality Assurance/ Quality Control environment in different responsible management functions within the pharmaceutical industry. International experience preferable. Substantial working experience with regulatory agencies in Europe as well as in the US
• Experience and knowledge in cGCP/cGLP/cGMP are essential
• Experience with diverse biotherapeutics portfolio especially on antibody, antibody drug conjugate and complex biologics are highly desirable
• Previous experience interfacing and guiding CRO activities related to clinical and preclinical study operations, as well as technical development and clinical trial material supply at CMO is highly desirable
• Detailed knowledge of drug development processes and worldwide regulatory guidelines are essential
• Previous experience with early and late stage development, as well as post-approval activities is a plus
BDU QA Lead
1. Implement Quality Standards and Procedures at the BDU in compliance with the Novartis Quality Manual and Policies for cGCP/cGLP/cGMP aspects.
2. Responsible for QA and QC strategy for the BDU in collaboration with BDU senior management.
3. Oversight of the CMO and CRO network for BDU related to clinical and preclinical study operations, including contractor approval.
4. Oversight of overall BDU technical development and clinical trial material supply.
5. Local QA representation and oversight of BDU clinical (cGCP) and preclinical (cGLP) infrastructure, systems and procedure setup in collaboration with Novartis Pharma QA.
Project QA Lead
6. Represent QA in Development sub-teams for BDU; core member of CMC teams: QA oversight of projects.
7. Responsible for QA strategy in assigned projects.
8. Maintains overall project quality overview, ensuring timely assessment and approval of GMP and development relevant documents, with decision making according to current SOPs and Novartis Policies.
9. Oversight of product manufacturing, including possible person-in-plant operations oversight.
10. Batch documentation review and product release.
11. Participate in Audits for BDU; act as audit Follow up Responsible Person.
12. Oversight of regulatory filing consistency checks, and lead for pre-approval inspection preparedness for products in phase 3.
13. Represent QA in clinical, preclinical/safety, DRA sub-teams for BDU in collaboration with Novartis Pharma QA.
Project Analytical Expert
14. Represent QC in Development sub-teams for BDU; as ad hoc team member in technical project teams and core member of analytical sub-team ; QC oversight of projects.
15. Responsible for QC strategy in assigned projects:
♦ Elucidate and regularly review/refine QC project plan with timelines. Communicate resource needs for QC, including sample amounts, request for new testing, new stability studies
16. Maintains project analytical quality overview. Timely assessment of analytical results and reports for potential OOE results after Lab approval.
17. Oversight and responsibility for implementation and execution of QC testing:
♦ Method validation/ transfer to/from other labs. Oversees know-how transfer from development to GMP testing labs
♦ Reviews project-specific documents authored by BDU, or delegate, (analytical specifications, qualification and evaluation reports) and ensures feasibility of lab testing in collaboration with Lab heads
♦ Writes detailed validation/transfer protocols. Performs data evaluation (incl. statistical analysis). Author of validation/transfer reports based on lab data provided
♦ Writes stability protocols and reports (DSR/RSR): prepares empty data tables, verifies filled data tables. Prepares overlays (e.g. Chromeleon), (statistical) data evaluation
18. Analytical documentation review and peer review of documents written by other project experts.
19. Participate in Audits for BDU; act as analytical subject matter expert when required.
20. Reviews technical submission documents from Reg-CMC, provides answers to HA questions. Prepares QC project overview if required for inspections.
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