Senior Director of Quality Control - Biopharma QC Strategy
Asahi-Kasei
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Benefits offered by this job
Job summary
Bionova Scientific LLC, a subsidiary of Asahi Kasei Medical, is seeking a Sr. Director of Quality Control in Fremont, CA. Lead the QC laboratories, set strategy, and ensure cGMP compliance across release, stability, and environmental monitoring.
The role requires an advanced degree and 15+ years in Analytical Sciences or GMP labs, with strong regulatory interaction experience. This hybrid position offers a competitive base salary and comprehensive benefits.
Qualifications
- Advanced degree required; 15+ years in Analytical Sciences, Quality Control, or GMP labs.
- Experience leading QC teams and driving regulatory compliance.
- Strong knowledge of biopharmaceutical development and cGMP requirements.
- Experience interacting with global regulatory agencies.
Responsibilities
- Provide strategic and tactical leadership for QC labs and operations.
- Apply analytical methods knowledge to support development, clinical, and commercial testing; troubleshoot investigations.
- Ensure compliance with global cGMP for release, stability, and environmental monitoring.
- Partner with clients and teams to assess risks and define analytical strategies.
- Oversee method development, transfer, qualification, and validation for programs.
Skills
Education
Job description
Bionova Scientific LLC, a subsidiary of Asahi Kasei Medical, is seeking a Sr. Director of Quality Control in Fremont, CA. Lead the QC laboratories, set strategy, and ensure cGMP compliance across release, stability, and environmental monitoring.
The role requires an advanced degree and 15+ years in Analytical Sciences or GMP labs, with strong regulatory interaction experience. This hybrid position offers a competitive base salary and comprehensive benefits.
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