Manager/Senior Manager, Supplier Quality Management (Contract)

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. For more information, please visit www.allogene.com, and follow @AllogeneTx on X (formerly Twitter) and LinkedIn.

About the role:

We are seeking a highly motivated individual in this exciting new area of cancer immunotherapy. In this role you will be responsible for the important elements of the Supplier Qualification Management (SQM) program and will work cross-functionally to execute and improve SQ programs.

Responsibilities (include but are not limited to):

• Responsible for managing the internal and external audit programs.
• Assures adherence to audit schedule, management of audit scheduling and logistics.
• Performs internal and external audits per applicable regulations and guidance.
• Evaluates audit responses as required and determines risks.
• Performs regulatory compliance intelligence review of suppliers.
• Responsible for supplier questionnaire management, including improving questionnaire content, coordination of questionnaire completion with suppliers, and evaluation of responses.
• Develop quality agreement templates and establish preferred, standard, and fallback terms.
• Conduct and/or facilitate quality agreement negotiations.
• Perform quality agreement periodic reviews.
• Perform and/or assist in supplier qualification activities and supplier monitoring activities.
• Participate in departmental and cross-functional process improvement initiatives and special projects as identified by management to support the business need.
• Assists in developing supplier performance metrics.
• Other duties as assigned.

Requirements:

• Bachelor’s degree in Engineering, Chemistry or biological sciences required.
• Advanced degree, ASQ Auditor certification, or ASQ Quality Engineer certification preferred.
• At least 10 years in quality assurance, manufacturing, QC or quality engineering
• Experience in auditing and supplier qualification in biopharmaceutical field required.
• Extensive working knowledge of quality system requirements such as US FDA GMP, GCP, EMA, and ICH guidelines and have a proven track record of successfully implementing these requirements.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
• Proficient in MS Word, Excel, Power Point, Visio, Project
• Experience with Veeva is a plus but not required.
• Candidates must be authorized to work in the US.
• Some travel may be required.

We offer a chance to work with talented people in a collaborative environment. 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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