Senior Director, QC Strategy & Operations
Bionova Scientific LLC
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Benefits offered by this job
Job summary
Bionova Scientific LLC in Fremont, CA seeks a Sr. Director of Quality Control to lead the QC function, set strategy, and oversee release testing, stability, and environmental monitoring for development and commercial programs.
The role requires an advanced degree and 15+ years in Analytical Sciences or GMP labs, with strong regulatory interactions and a track record in method transfer/validation. Hybrid work arrangement and strong compensation are offered.
Qualifications
- 15+ years of leadership experience in Analytical Sciences or GMP labs.
- Strong biopharmaceutical development understanding from bench to market.
- Experience interfacing with global regulatory agencies.
Responsibilities
- Provide strategic leadership for QC laboratories and related operations.
- Oversee method development, transfer, qualification, and validation for programs.
- Partner with QA to maintain data integrity and fit-for-purpose QC systems.
- Drive continuous improvement and KPIs to improve lab efficiency and stability.
- Lead and develop the QC team to enhance technical capability and compliance.
Skills
Education
Job description
Bionova Scientific LLC in Fremont, CA seeks a Sr. Director of Quality Control to lead the QC function, set strategy, and oversee release testing, stability, and environmental monitoring for development and commercial programs.
The role requires an advanced degree and 15+ years in Analytical Sciences or GMP labs, with strong regulatory interactions and a track record in method transfer/validation. Hybrid work arrangement and strong compensation are offered.
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