Sr. Director of Quality Control

The Sr. Director of Quality Control is a member of the Quality and Compliance Leadership Team responsible for leading Bionova Scientific's QC function. This role sets strategy and provides oversight for sample management, stability, in-process and environmental monitoring, release testing, method transfer, qualification, validation, and related QC operations.

The role supports client timelines by developing robust analytical transfer and qualification strategies in collaboration with clients and Bionova's Analytical Development team.

Location:

Fremont, CA Benefits

Direct Hire Medical, Dental, Vision, 401K (match up to 5%, plus an additional 3%, total 8%)Paid time off Annual Bonus eligible

Primary 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.

Required Skills:

Advanced degree in Pharmaceutics, Biochemistry, Chemistry, Biochemical Engineering, or a related discipline; equivalent experience may be considered.
15+ years of leadership experience in Analytical Sciences, Quality Control, or a related 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.

The base compensation range for this role is $240,000-$280,000. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.#LI-MG1#hybrid