Senior Director, Quality Systems and Compliance
Allogene Therapeutics - South San Francisco, CA
Hiring: Senior Director, Quality Systems and Compliance Company: Allogene Therapeutics Location: South San Francisco, CA Job Posted Time: 2026-09-10 11:51:43 Target Skills & Keywords : Quality Assurance, Regulatory Compliance, Risk Management About the job Experience: •10-12 years' experience in Pharma/Biotech industry including 5-6 years management experience with focus on Quality Systems and Compliance. •12 years' experience in Pharma/Biotech industry including 5-6 years management experience with focus on Quality Systems and Compliance. Required Skills: •This role will be based out of our South San Francisco office, with the flexibility to work remotely up to two days per week. •As a member of the Quality Leadership Team and key advisor on global compliance policies and strategy, collaborate with peers and site leadership to ensure company goals and regulatory commitments and standards are adhered to. •Promote a strong culture of quality, built on ownership, accountability, collaboration, continuous improvement, and risk management. •Serve as the lead for internal inspection readiness activities, supplier audits, regulatory inspections, and health authority compliance related interactions. •Lead compliance risk management assessments, ensuring timely and effective remediation of findings, deviations, and CAPA. •Oversee supplier quality regulatory compliance and risk management programs that support sustainable inspection readiness. •Define and oversee initiatives to mature quality systems in preparation for PLI readiness and product commercialization •Advance digital solutions and continuous improvement initiatives that strengthen quality performance and optimize processes. Qualifications: •B.S. in Biological Sciences, Chemistry, Engineering. Advanced degree preferred. •Minimum 10-12 years' experience in Pharma/Biotech industry including 5-6 years management experience with focus on Quality Systems and Compliance. •In-depth knowledge of Quality Management System requirements (US, EU) for pharmaceutical and biotech commercial manufacturing and supporting activities. •Excellent interpersonal and communication skills clearly conveying findings to a variety of audiences, including senior management. •Adept at interpreting and managing risks, balancing operations excellence and regulatory requirements to implement improvements •Comfortable in a fast-paced small company environment with minimal direction and able to adjust based upon changing priorities. •Candidates must be authorized to work in the US. Compensation: •$230,000 - $270 / year •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!