The position reports to Head Biologics with a vision of managing Quality at multilocation plans
Responsibilities for this role include:
1. Ensure adherence to the GMP requirements of the US, EMA as well as other countries world-wide.
2. Building and Management of Quality Assurance and Quality Control organizations
3. Development of Quality Management Systems for Biologicals QA and QC
4. Contribution to facility and equipment design for Biologicals template facilities
5. Contribution to regulatory documents supporting the various biologicals products
6. Due-diligence activities for new in-licensed products and collaborations
7. GMP compliance within Clinical and Commercial Manufacturing facilities
8. Quality review of analytical testing methods within Quality Control
9. Ownership of the Master Validation Plan for different products and facilities.
10. Ownership of documentation related to DS and DP manufacturing, QC testing equipment, clean utilities and facilities as well as the Site Master Plan for facilities
11. Authorship of overarching guidelines for Quality Management at the different manufacturing locations
12. Implementation of risk assessment and risk mitigation strategies at different phases of product development
13. Lead successful audits from world-wide regulatory authorities and environmental/safety agencies
14. Build and manage Quality Control laboratories for analytical, cell-based and microbiological assays
Ph.D./MS/MTech/Msc in Chemical Engineering, Biotechnology, Biochemistry or Microbiology with greater than 15-20years experience working with Biologicals. Mabs experience is required and experience with Biosimilars is desirable.
International experience is preferred, though experience with global collaborations will also be considered.
Experience with interacting with international auditors (US FDA, EMA, ANVISA amongst others)
our clients would prefer candidates based in US and wanting to relocate to India..