Sr. Director of Quality Control

About the role

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.

Key responsibilities

• Provide strategic and tactical leadership for 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.
• 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.

Required profile

• Advanced degree in Pharmaceutics, Biochemistry, Chemistry, Biochemical Engineering, or related discipline (or equivalent experience).
• 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.

Required skills

• Analytical method development, optimization, transfer, qualification and validation.
• cGMP compliance and data integrity expertise.
• Stability testing and environmental monitoring.

What we offer

• Base compensation range $240,000‑$280,000 per year.
• Medical, dental, and vision benefits.
• 401(k) match up to 5% plus an additional 3% (total 8%).
• Paid time off.
• Eligibility for annual bonus.