Senior Director, Validation and Quality Engineering

About the role

Allogene Therapeutics is seeking a highly motivated Senior Director, Validation and Quality Engineering, in the Quality group. The ideal candidate is an individual who is interested in working in a fast-paced, dynamic, and highly collaborative biotech environment, with the willingness and ability to successfully take on new challenges. The position is a hybrid role and requires 3 days a week at either Allogene’s headquarters in South San Francisco or Allogene’s manufacturing facility in Newark, CA.

Responsibilities

• Develop and oversee validation strategies and validation master plans for Allogene products, facilities, and computer systems, aligned with business objectives and evolving regulatory requirements.
• Direct all validation activities, including Commissioning, Qualification, and Validation (CQV) of facilities and equipment; Cleaning Validation; Aseptic Process Validation; Process Validation (PV); and Shipping Validation.
• Lead a team of validation and quality engineering professionals to ensure timely delivery of validation activities, and manage contractors and vendors as needed.
• Establish and maintain a GxP-compliant validation program through the development of procedures and policies.
• Partner cross-functionally to ensure validation and QE deliverables meet business needs and regulatory expectations.
• Serve as the company authority on validation and quality engineering, including quality data science, in support of regulatory submissions and inspections.
• Champion the use of data analytics and operational excellence tools to drive continuous improvement and innovation.
• Provide statistical expertise to enhance process understanding, analytical performance, and overall product quality control.
• Lead and support risk management activities across company operations.
• Monitor industry trends and actively engage in external forums to identify and implement best practices and emerging technologies relevant to cell therapy.
• Contribute to the build-out and continuous improvement of the Allogene GxP Quality Management System, including support of management review processes.
• Provide strategic leadership during regulatory inspections and third-party audits, ensuring timely and effective closure of observations.
• Interface with regulatory agencies during inspections and technical discussions, representing Allogene’s validation strategy and compliance posture.

Position Requirements & Experience

• Bachelor’s degree in engineering, chemistry, or biological sciences required; PhD preferred. Cell and gene therapy experience is a plus. ASQ Auditor certification and ASQ Quality Engineer certification are preferred. At least 12 years in technical quality assurance, manufacturing, or engineering roles, with at least 5 years in a related management role.
• Experience in technical quality assurance, manufacturing, or engineering in a related management role.
• Comprehensive knowledge of GXP regulations, guidance, and industry best practices.
• Extensive experience in the pharmaceutical and biologics industry required.
• Experience in performing risk management exercises in support of GMP operations.
• Proficient in drafting and completing highly technical documents and presentations.
• Ability to analyze and develop solutions to complex problems.
• Excellent interpersonal, verbal, written, and presentation skills to explain complex concepts and critical findings clearly to a variety of audiences, including senior management.
• Proficient in MS Office tools and statistical software, with solid knowledge of Data Lake, R Shiny, Tableau, and other applications.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.