Associate 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.

Job Description:

Allogene is seeking an Associate Director of External Quality to provide quality oversight of Contract Manufacturing Operations (CMO) and material suppliers. This position will require active engagement and strategic vision for the QA role in the company and will report to Head of External Quality. The position will be responsible for supporting quality management system and providing direction and decision making with regard to quality operations. Role will entail operating in a fast-paced, highly dynamic environment with key company work partnerships including both internal and external stakeholders. Excellent communication skills and demonstrated ability to work well with others will be essential.

Responsibilities include, but are not limited to:

· Provides Quality leadership 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. In addition, collaborate with Manufacturing, Supply Chain and CMC Program Management to assure on time delivery of approved products.

· 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.

· Provide quality oversight of material suppliers

· Provide QA guidance and support for CMO and supplier qualification

· Responsible for executing Quality Assurance (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.

· Manage change notifications and CMO/supplier-initiated changes

· Manage CMO and supplier investigations and corrective actions

· Manage completion of audit observation responses in a timely and effective manner

· Align and negotiate Quality Agreement terms with internal stakeholders and external partners

· Collaborate and support analytical transfers, qualification and validation as needed

· Provides guidance with respect to regulations, guidelines, and emerging inspectional trends in developing Quality management systems and functionality

· Pro-actively and independently identify and mitigate key cross-functional issues with limited need to escalate.

· Support the preparation of relevant sections of regulatory submissions and response materials

· Drives continuous improvement utilizing quality tools such as lean, six sigma, and risk management.

· Deliver project status updates to senior/executive management as needed.

· Other duties as assigned.

Requirements:

· At least 7 years of experience in bio-pharmaceutical field with manufacturing operations oversight 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.

· 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.

· Demonstrated ability to successfully interact with regulatory health authorities at inspections (prior experiencing leading inspections is required).

· Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.

· 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 organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.

· Proficient in MS Word, Excel, PowerPoint, Visio, Project, and statistical software.

· Travel maybe required up to 15%, and 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 $170,000 to $210,00 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, designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

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