Director, Analytical QC & GMP Excellence

GeneFab; Alameda (CA); On-site; USD 180,000 - 230,000; Full time

Job summary

GeneFab is seeking an Associate Director, Analytical Quality Control to provide strategic and operational leadership for the QC organization supporting GMP manufacturing, product release, stability testing, and analytical method lifecycle management.

You will lead a team of QC professionals, ensure timely and accurate data delivery, and drive continuous improvement across method development, validation, release, and stability testing.

Qualifications

• 10+ years of experience in biopharmaceutical analytical testing within GMP environments.
• Leadership experience (5+ years) leading QC teams.
• Strong knowledge of cGMP, ICH, FDA, EMA regulatory expectations.

Responsibilities

• Provide strategic and operational leadership for the analytical quality control organization.
• Lead and develop a team of QC professionals and foster a culture of excellence.
• Oversee analytical method development, qualification/validation, and release/stability testing.
• Ensure timely and accurate data delivery and documentation practices.
• Collaborate with Manufacturing, MSAT, AD, and Validation for technology transfer.
• Oversee QC deviations, CAPAs, and change controls; support QMS improvements.

Skills

Leadership

Quality systems

Collaboration

Strategic thinking

Education

MS/BS in Analytical Chemistry or related

Job description

GeneFab is seeking an Associate Director, Analytical Quality Control to provide strategic and operational leadership for the QC organization supporting GMP manufacturing, product release, stability testing, and analytical method lifecycle management.

You will lead a team of QC professionals, ensure timely and accurate data delivery, and drive continuous improvement across method development, validation, release, and stability testing.