Strategic QC Director: cGMP, Validation & Compliance

Bionova Scientific LLC; United States; Hybrid; USD 240,000 - 280,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401K with match (up to 8%)

Paid time off

Annual bonus eligible

Job summary

Bionova Scientific LLC in Fremont, CA is seeking a Sr. Director of Quality Control to lead the QC function within our growing biologics CDMO.

This role sets strategy for sample management, stability, in-process and environmental monitoring, release testing, method transfer, qualification, validation, and related QC operations. You will partner with clients and internal teams to develop robust analytical transfer strategies, ensure global cGMP compliance, and drive continuous improvement in lab

Qualifications

• Advanced degree in Pharmaceutics, Biochemistry, Chemistry, Biochemical Engineering, or related discipline.
• 15+ years of leadership experience in Analytical Sciences, Quality Control, or a GMP laboratory environment.
• Strong understanding of biopharmaceutical development, from cell line generation through market authorization.
• Direct experience interacting with global regulatory agencies.
• Strong experience with method optimization, transfer, qualification, and validation for release and stability testing.
• Extensive knowledge of cGMP requirements and data integrity expectations.

Responsibilities

• Provide strategic and tactical leadership for Bionova Scientific’s QC laboratories and related operations.
• Apply deep technical expertise in analytical methods to support development, clinical, and commercial testing, including troubleshooting and investigations.
• Ensure phase-appropriate compliance with global cGMP expectations for release, stability, and environmental monitoring programs.
• Partner with clients and internal teams to assess program risks and define analytical strategies that support timely, science-based decisions.
• Oversee method development, transfer, qualification, and validation for development and commercial programs.
• Partner with Quality Assurance to maintain fit-for-purpose QC quality systems and data integrity.
• Drive continuous improvement initiatives, performance metrics, and KPIs to improve laboratory efficiency, effectiveness, and process stability.
• Lead, coach, and develop the QC team to strengthen technical capability, compliance, and operational execution.
• Communicate goals, risks, decisions, and results effectively across development and commercial teams.

Skills

Analytical Leadership

cGMP Knowledge

Data Integrity

Education

Advanced degree in Pharmaceutics, Biochemistry, Chemistry, Biochemical Engineering, or related discipline

Job description

Bionova Scientific LLC in Fremont, CA is seeking a Sr. Director of Quality Control to lead the QC function within our growing biologics CDMO.

This role sets strategy for sample management, stability, in-process and environmental monitoring, release testing, method transfer, qualification, validation, and related QC operations. You will partner with clients and internal teams to develop robust analytical transfer strategies, ensure global cGMP compliance, and drive continuous improvement in lab