Provide quality oversight for Biologics development activities and ensure compliance with GMP, regulatory requirements, and internal quality systems.
Key Responsibilities:
- Review and approve analytical and process development documents.
- Review method validation, process validation, technology transfer, deviations, CAPAs, and change controls.
- Ensure compliance with FDA, EMA, ICH, and GMP requirements.
- Support audits, inspections, and quality risk management activities.
- Work closely with Analytical Development, Process Development, Manufacturing, and Regulatory Affairs teams.
Qualifications:
- M.Sc./Ph.D. in Biotechnology, Biochemistry, Microbiology, Pharmaceutical Sciences, or a related field.
- 10+ years of experience in Development QA/Quality Assurance within Biologics/Biosimilars.
- Strong experience in analytical and process document review.
- Positive understanding of biologics development, GMP, and global regulatory requirements.