Senior Director, Quality Control & Compliance

Celgard; Fremont (CA); Hybrid; USD 240,000 - 280,000; Full time

Benefits offered by this job

Direct Hire

Medical, Dental, Vision, 401K (match 5

Paid time off

Annual Bonus eligible

Job summary

Bionova Scientific LLC in Fremont, CA seeks a Sr. Director of Quality Control to lead the QC laboratories and quality systems, ensuring compliant testing across development, clinical, and commercial programs.

You will set strategy for method transfer, validation, and release testing, partner with clients and regulatory bodies, and coach the QC team to deliver timely, science-based decisions while advancing cGMP compliance.

Qualifications

• 15+ years of leadership experience in Analytical Sciences, Quality Control, or GMP labs.
• Strong understanding of biopharmaceutical development and regulatory expectations.
• Experience interacting with global regulatory agencies and leading method transfer/validation.

Responsibilities

• Provide strategic and tactical leadership for Bionova Scientific’s QC laboratories and operations.
• Oversee method development, transfer, qualification, and validation for development and commercial programs.
• Ensure phase-appropriate compliance with global cGMP expectations for release, stability, and environmental monitoring.
• Lead, coach, and develop the QC team to strengthen technical capability and compliance.
• Communicate goals and results across development and commercial teams.

Skills

People leadership

Regulatory understanding

cGMP knowledge

Analytical testing

Quality strategy

Education

Advanced degree

Job description

Bionova Scientific LLC in Fremont, CA seeks a Sr. Director of Quality Control to lead the QC laboratories and quality systems, ensuring compliant testing across development, clinical, and commercial programs.

You will set strategy for method transfer, validation, and release testing, partner with clients and regulatory bodies, and coach the QC team to deliver timely, science-based decisions while advancing cGMP compliance.