Job Description
Quality Assurance Manager for Biomanufacturing Facility
The Quality Assurance Manager will oversee the Quality Assurance team at the Incyte Biomanufacturing facility in Yverdon-les-bains.
The manager will ensure that all quality-related activities are performed according to company policies, cGMP, Swiss, EU and US FDA Regulations.
Key Responsibilities
1. Lead the Quality Assurance team of Quality Control and Release
2. Manage consultants and personnel supporting analytical transfer activities
3. Oversee method transfers and validation, including approval of associated protocols and reports (raw materials and Drug Substance)
4. Ensure release of Raw Materials and Drug Substances according to company policies and plans
5. Develop and maintain strong partnerships with Supply Chain and Regulatory functions
6. Represent QA for laboratory SOPs development, update, and periodic review
7. Approve specifications and methods
8. Drive resolution of QC deviations, OOS, and OOT
9. Oversight of stability program, including approval of plans and reports
10. Perform internal audits and GEMBA to maintain facility inspection readiness
11. Coach QC personnel on quality compliance matters
12. Support Annual Product Reviews for QC part
13. Approve sampling plans
14. Maintain Incyte Quality System
15. Lead risk assessments and support commissioning and qualification of laboratory equipment
16. Support environmental and utilities monitoring programs
17. Biologic Process Sciences SOPs and equipment commissioning and qualification
18. Support incoming goods and vendor assessments
19. Support Health Authorities inspections as QA Subject Matter Expert
20. Interpret GMP, regulatory requirements, and Quality systems regulations in QC and implement as applicable
21. Foster Good Manufacturing Practices (cGMPs) understanding and application by Bioplant employees
22. Perform responsibilities in accordance with company policies, procedures, regulations, and safety requirements
23. Work in a right first time and site readiness approach for regulatory inspections (Swissmedic and International)
24. Contribute positively to business integrity and ethics
25. Act within compliance and legal requirements, company guidelines
26. Delegate Associate Director QA release
Requirements
1. Bachelor's Degree in Chemical Engineering, Bio-engineering, Bioprocessing
2. Expertise in microbiology
3. Relevant experience in Quality Assurance role in biopharmaceutical manufacturing environment
4. Thorough knowledge of biotechnology processes, manufacturing, and laboratory equipment
5. Demonstrated proficiency in good practice requirements cGMP, biopharmaceutical industry regulations, and standards related to qualification and validation
6. Proficiencies with quality systems, computerized systems, testing, and production systems integration
7. Experience in Health Authorities inspections
8. Ability to make pragmatic and compliant decisions
9. Strong results orientation and committed team member
10. Excellent written and verbal communication skills in English, French