Senior QC Director — Biopharma, cGMP Strategy & Leadership

Asahi Kasei Bioprocess America, Inc.; Fremont (CA); Hybrid; USD 240.000 - 280.000; Vollzeit

Benefits dieser Stelle

Medical, Dental, Vision, 401K (match 5

Paid time off

Annual Bonus eligible

Zusammenfassung

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

This hybrid, full-time role guides analytical strategy, sample management, in-process and environmental monitoring, release testing, method transfer, qualification and validation across development and commercial programs. The successful candidate will provide strategic leadership, ensure global cGMP compliance, partner with clients and internal teams,

Qualifikationen

• 15+ years of leadership experience in Analytical Sciences or Quality Control.
• Strong understanding of biopharmaceutical development from cell line generation to market authorization.
• Direct experience interacting with global regulatory agencies.
• Strong experience with method optimization, transfer, qualification, and validation for release and stability testing.

Aufgaben

• 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.
• 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.

Jobbeschreibung

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

This hybrid, full-time role guides analytical strategy, sample management, in-process and environmental monitoring, release testing, method transfer, qualification and validation across development and commercial programs. The successful candidate will provide strategic leadership, ensure global cGMP compliance, partner with clients and internal teams,