Director, External Quality

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 is seeking a Director of External Quality to lead the Quality Assurance function for Contract Manufacturing Operations (CMO) Oversight and Supplier Quality Management (SQM). This position will require active engagement and strategic vision for the QA role in the company and will report to the Head of CMC Quality. The position will be responsible for providing direction and decision regard to quality oversight of starting material (SM), drug substance (DS) and drug product (DP) and labeling and packaging operations at the CMO.

Additionally, this role will oversee the quality of material suppliers, including media, chemicals, excipients, single-use systems, and primary and secondary packaging components. The position is a hybrid role and requires 3 days a week at either Allogene headquarters in South San Francisco or Allogene’s manufacturing facility in Newark, CA.

Responsibilities include, but are not limited to:

• Provide Quality functional leadership in the Quality team including hiring and managing, high performing quality assurance staff designed to meet the technical and compliance requirements
• Provide QA support for the manufacturing and disposition of GMP starting materials, Drug Substance, Drug Product, and packaged and labeled products. Responsible for disposition of GMP products utilizing trained and qualified QA staff.
• Collaborate with Manufacturing, Supply Chain and CMC Program Management to assure on time delivery of approved products.
• Provide quality oversight of material suppliers and QA guidance for our CMO and supplier qualification
• Work directly with operating entities (internal and CMOs) to ensure that products (i.e., SM, DS, DP, and packaged and labeled product) meet all required quality standards and specifications.
• Influence other functional departments to ensure that CMOs achieve and maintain the appropriate levels of GMP compliance and provide quality services and work with CMOs to ensure their cGMP processes and procedures provide continuous evaluations and improvements to their quality systems.
• Build strong interdependent relationship with CMO Project Management Counterparts, QA and QC teams in order to assess the as is state and risks for action-oriented improvement plans.
• Provide QA guidance and support for supplier qualification, technology transfer, scale-up, validation and other GMP activities associated with products manufactured by CMOs.
• Facilitate the resolution of quality issues with internal and external parties in a timely manner and coordinate communications with CMOs/suppliers and internal technical product teams for quality issues.
• Execute QA programs and activities; this includes assisting with training and auditing programs, as well as the review of SOPs, investigations, specifications, methods, reports and manufacturing records.
• Align and negotiate Quality Agreement terms with internal stakeholders and external partners
• Represent the Quality function in product development (CMC) teams, engaging all quality stakeholders to ensure product deliverables are met through the product lifecycle.
• Review and approve CMC sections of regulatory filings as needed.
• Assist the Quality Management Systems function in the development, establishment and maintenance of internal Quality Systems processes and procedures (e.g., change control, training, audit, CMO and supplier management, deviation and CAPA) that complies with applicable GMP standards, regulations and guidelines.
• Drives continuous improvement utilizing quality tools such as lean, six sigma, and risk management.
• Contribute to the development and maintenance of a positive team culture
• Role will entail operating in a fast-paced, highly dynamic environment with key company work partnerships including both internal and external stakeholders.

Position Requirements & Experience:

• Bachelor’s degree in Engineering, Chemistry or biological sciences required; advanced degree preferred (education or training in cell culture and gene therapy a plus), ASQ Auditor certification, ASQ Quality Engineer certification preferred.
• At least 12 years in a technical role in manufacturing, QA, QC and/or quality engineering with demonstrated manufacturing plant experience in the bio-pharmaceutical, pharmaceutical, or medical device with at least 5 years in a related management role.
• Extensive working knowledge of quality system requirements such as US FDA GMP, EMA, and ICH guidelines and have a proven track record of successfully implementing these requirements.
• Knowledge of fundamental quality engineering principles such as process capability, process control, and structured problem solving, including root cause investigations.
• Proficient in MS Word, Excel, PowerPoint, Visio, Project, and statistical software.
• Demonstrated ability to successfully interact with regulatory health authorities at inspections (prior experiencing leading inspections is required).
• Ability to effectively work in a fast-paced, start-up environment, while dealing with ambiguity.
• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
• Excellent communication skills and demonstrated ability to work well with others will be essential.
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
• Ability to work independently and as part of a team, strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
• Candidates must be authorized to work in the U.S
• Travel up to 10%

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 $200,000 to $230,000 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.

#LI-HYBRID