Head of Quality Control & Strategy

Pharmaceutical Compliance Forum Inc; Fremont, Northern (CA, KY); Hybrid; USD 240,000 - 280,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401K with match

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 function, setting strategy and overseeing release testing, stability, in-process and environmental monitoring.

You will partner with clients and development teams to ensure compliance with global cGMP, drive continuous improvement, and coach the QC staff to strengthen technical capability and data integrity.

Qualifications

• 45+ years? (error)

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.
• Ensure phase-appropriate compliance with global cGMP for release, stability, and environmental monitoring programs.
• Partner with clients and internal teams to assess program risks and define analytical strategies.
• 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, KPIs to improve laboratory efficiency, effectiveness, and process stability.
• Lead, coach, and develop the QC team to strengthen technical capability and compliance.
• Communicate goals, risks, decisions, and results across teams.

Skills

Leadership

Analytical Sciences

cGMP compliance

Regulatory interaction

Method transfer

Data integrity

Education

Advanced degree in pharmaceutics/biochemistry/chemistry

Job description

Bionova Scientific LLC in Fremont, CA, seeks a Sr. Director of Quality Control to lead the QC function, setting strategy and overseeing release testing, stability, in-process and environmental monitoring.

You will partner with clients and development teams to ensure compliance with global cGMP, drive continuous improvement, and coach the QC staff to strengthen technical capability and data integrity.