Senior Director, QC Strategy & Compliance

Asahi Kasei; Iowa (LA); On-site; USD 240,000 - 280,000; Full time

Benefits offered by this job

Direct Hire

Medical, Dental, Vision, 401K

Paid time off

Annual bonus eligible

Job summary

Bionova Scientific LLC, a subsidiary of Asahi Kasei Medical, is seeking a Sr. Director of Quality Control to lead QC laboratories and ensure cGMP compliance across release, stability, and environmental monitoring programs.

Location is Fremont, CA, with a strong emphasis on analytical strategy and client collaboration. The role requires an advanced degree in a related discipline and 15+ years in Analytical Sciences or GMP laboratories, plus experience with regulatory interactions and method

Qualifications

• 15+ years of leadership experience in Analytical Sciences, Quality Control, or GMP labs.
• Strong understanding of biopharmaceutical development and regulatory expectations.
• Experience with method development, transfer, qualification, and validation for release and stability testing.

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.
• 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

Leadership experience

Regulatory interaction

cGMP knowledge

Analytical method transfer/validation

Education

Advanced degree in Pharmaceutics Biochemistry Chemistry Biochemical Engineering or related

Job description

Bionova Scientific LLC, a subsidiary of Asahi Kasei Medical, is seeking a Sr. Director of Quality Control to lead QC laboratories and ensure cGMP compliance across release, stability, and environmental monitoring programs.

Location is Fremont, CA, with a strong emphasis on analytical strategy and client collaboration. The role requires an advanced degree in a related discipline and 15+ years in Analytical Sciences or GMP laboratories, plus experience with regulatory interactions and method