Associate Director of Quality Control

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

About the role

TheAssociate Director,AnalyticalQuality Controlis responsible forproviding strategic and operational leadership for the analytical quality control organization supporting GMP manufacturing, product release, stability testing, and analytical method lifecycle management. The role oversees QC analytical laboratories and ensures that all testing activitiescomply withcGMP regulations, regulatory expectations, and company quality standards.

What you’ll do

• Ensures that QC Systems and practices are developed and implementedin accordance withthe requirements of GMP.
• Lead, mentor, and develop a team of quality control professionals, fostering a culture ofexcellence, collaboration, and continuous improvement.
• Demonstrate experience performing and managing analytical method development, phaseappropriate methodqualification/validation, and release and stability testing.
• Ensures that delivery of data isaccurateandon time.
• Provide mentorship to directreports andmaintainclear communication on performance to direct reports.
• Provenproficiencyworking with quality systems including SOPs, protocols and reports,releaseand stability data review, OOT and OOS management, Good Documentation Practices, LIMS and cGMP data traceability, Deviations, and Change Management.
• Owner of the Quality control metrics to assess overall and individual performance to ensure continuous improvement opportunities are being assessed and applied.
• Manage QC inputs to Annual ProductQuality Reviews and Quality Management Reviews.
• Oversee trending of commercial product quality (Drug Substance, Drug Product, Finished Product) and commercial QC analytical method performance.
• Manage QC deviations, CAPAs, and change controls for clinical and commercial products.
• Collaborate with Manufacturing, MSAT, AD, and Validation to ensure effective technology transfer from internal departments and external companies.
• OverseeManagement team to ensure subject matterexpertiseis instilled to develop scientists’ motivation, education, efficiency, and performance management of individuals.
• Coordinate with AnalyticalDevelopmentresources to optimize test methods and execution to streamline laboratory functions,operations,and improve overall quality of such functions.
• Oversee and support method validation and verification activities, and method transfer between sites for clinical/commercial products.
• Work withthe QualityAssurance Department to improve and sustain an effective and efficient quality management system.
• Responsible for GMP-compliant analytical laboratory and safe working environment.

Qualifications

• MS or BS in Analytical Chemistry, Biochemistry, Molecular Biology, Pharmaceutical Sciences, or related scientific discipline.
• 10+ years of experience in biopharmaceutical analytical testing within GMP environments.
• 5+ years of leadership experience.
• Experience supporting clinical and commercial manufacturing programs.
• Strong knowledge of regulatory requirements and standards governing bio-pharmaceutical quality control (cGMP, ICH, FDA, EMA, etc.).