Senior Director, Validation and Quality Engineering

About Allogene:

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.

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.

In this role, you will be responsible for developing and leading the validation function at Allogene in support of process, analytical, facility, equipment, and computer system validation. You will work closely with senior leadership and respective project teams to develop validation strategy and project plans to ensure timely and compliant execution of validation deliverables. In addition, you will be responsible for establishing the quality engineering (QE) function, focused on implementing process improvement tools and supporting the identification and execution of operational improvement efforts. You will work closely with senior leadership and respective project teams to establish a quality data science roadmap to implement a lifecycle approach for product quality control strategies.

Responsibilities include, but are not limited to:

• 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.
• Candidates must be authorized to work in the U.S.

We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $230,000 to $270,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

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