Director, Quality Assurance

Position Summary

The Associate Director of Quality Assurance is responsible for the strategic development, leadership, and management of Quality Assurance operations supporting CMC activities and clinical manufacturing programs. This role ensures compliance with FDA, EMA, ICH, and other applicable global regulatory requirements while supporting Phase I, II, and III investigational products. The position will serve as a key quality leader, partnering cross-functionally to drive quality culture, compliance, operational excellence, and continuous improvement initiatives across the organization.

Key Responsibilities

+ Provide strategic leadership and oversight of Quality Assurance activities supporting clinical manufacturing and CMC operations.

+ Ensure compliance with current Good Manufacturing Practices (cGMP), 21 CFR Parts 210 and 211, ICH Guidelines, EU GMP regulations, and applicable company policies.

+ Lead lot disposition activities, including batch record review, in-process and release testing review, stability data review, and final product release decisions.

+ Oversee quality events related to GMP products, manufacturing processes, facilities, and systems, ensuring timely investigation, resolution, and documentation.

+ Review and approve development activities supporting GMP readiness, including development studies, technical reports, engineering activities, and related documentation.

+ Partner with cross-functional teams to promote and champion the Quality Risk Management (QRM) program.

+ Develop and maintain a phase-appropriate validation strategy and validation lifecycle program.

+ Lead quality-related discussions, investigations, risk assessments, deviations, CAPAs, and change control activities to ensure product quality and regulatory compliance.

+ Collaborate with Facilities, Manufacturing, Engineering, and technical subject matter experts to support equipment qualification and lifecycle management activities.

+ Work closely with Quality Systems to administer and continuously improve cGxP training programs for manufacturing and related functional groups.

+ Serve as the primary quality representative during regulatory inspections, customer audits, and third-party assessments.

+ Provide technical guidance and oversight for quality deviations, laboratory investigations, and change control processes to ensure thorough, compliant, and timely resolution.

+ Oversee the raw material quality program, including incoming material review and QA release activities.

+ Develop, implement, and maintain quality procedures, policies, and programs that support cGxP compliance and operational effectiveness.

+ Support regulatory submissions by contributing quality-related content and documentation.

+ Drive a culture of continuous improvement by identifying opportunities, implementing initiatives, and monitoring progress against key deliverables.

+ Perform additional duties and responsibilities as assigned.

Education

+ Bachelor's degree in Life Sciences, Chemistry, Biology, Pharmaceutical Sciences, Engineering, or a related scientific discipline required.

Experience

+ Minimum 10 years of experience within the biotechnology, pharmaceutical, or regulated life sciences industry.

+ At least 6 years of progressive Quality Assurance experience in GxP-regulated environments.

+ Minimum 5 years of direct people management and leadership experience.

+ Experience supporting clinical manufacturing programs and CMC operations for investigational products.

+ Experience hosting and supporting Health Authority inspections and external audits.

+ Prior cell therapy experience is highly desirable.

Technical Knowledge & Skills

+ Extensive knowledge of cGMP regulations and pharmaceutical quality systems.

+ Strong understanding of FDA regulations, including 21 CFR Parts 210 and 211, as well as EMA, ICH, ISO, and other applicable global regulatory requirements.

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Experience with validation programs, quality risk management, deviations, CAPA, change control, and batch disposition processes.

+ Proficiency with electronic quality and laboratory systems, such as eQMS, LIMS, and related platforms.

+ Strong problem-solving, investigation, and risk assessment capabilities.

+ Excellent written and verbal communication skills with the ability to influence cross-functional stakeholders.

+ Demonstrated ability to lead teams, manage competing priorities, and drive organizational performance.

Job Type & Location

This is a Contract position based out of South San Francisco, CA.

Pay and Benefits

The…