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Job Description
Job Description: Lead the QC Shared Projects team to support manufacturing, testing, and release of drug substance and sterile drug product. Develop a training structure and program for ongoing learning and development in QC. Ensure audit readiness, compliance with company policies, and evolving health authority regulations.
Responsibilities:
- Lead the QC Shared Projects team to support manufacturing, testing, and release of drug substance and sterile drug product.
- Develop a training structure and program for ongoing learning and development in QC.
- Ensure audit readiness, compliance with company policies, and evolving health authority regulations.
- Develop continuous improvement initiatives to facilitate cost saving and performance excellence.
- Coach, develop staff, and complete performance appraisal reviews.
- Support QC planning and scheduling activities as required.
Qualifications & Experience:
- Bachelor/Masters in Science or Science related discipline.
- Minimum of 6 years experience in the Pharmaceutical Industry.
- Deep understanding of GMP/GDP principles.
- Proven leadership and people management skills.
- Experience with regulatory agencies, US and EMA GMP regulations.
- Demonstrated understanding of test methods and instrumentation associated with biopharmaceutical processes.
Skills:
- QC Manager
- Projects
- Biotech
- Quality Control