Manager, Quality Assurance, Supplier and Vendor Audit Program

Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response. We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency. The incumbent is responsible for the design, execution and oversight of the supplier and vendor oversight program as well as the internal audit program within the Quality Assurance team. This role will be responsible for assessing GxP suppliers and executing questionnaires and audits as required. The incumbent will create and maintain the audit schedule and the approved supplier list. This is a cross-functional role that will ensure the organizations suppliers and vendors are acceptable to support GxP processes. KEY ROLE AND RESPONSIBILITIES: Create the annual audit schedule, both internal and external, and report on progress against activities and timelines Lead cross-functional teams in the evaluation of suppliers and vendors to determine quality and criticality Document, track, distribute and follow-up actions resulting from supplier questionnaires captured in the Quality Management System Plan, execute and report on virtual and on-site audits of suppliers and vendors Plan, execute and report on internal audits Maintain the Approved Supplier List Support third-party audits hosted onsite Own and facilitate the Material Review Board Participate in cross-functional teams for bringing in new materials and vendors PREFERRED EDUCATION: BA/BSc with a minimum of 10 years’ experience in auditing / quality assurance ; or MBA or MSc with a minimum of 7 years’ experience Professional Auditor Certification PREFERRED EXPERIENCE: Minimum 12 years’ experience in GMP biopharmaceutical operations with a minimum of 8 years’ experience in GMP Quality and a minimum of 5 years’ experience as an auditor Demonstrated experience in Clinical and GMP manufacturing Proven experience with quality management systems (e.g. Deviations, CAPA, Risk, etc) KNOWLEDGE, SKILLS AND ABILITIES: Deep knowledge and understanding of the regulations that govern GMP manufacturing and specifically cell therapy companies in the US, Canada, Australia, Europe and Japan Ability to occasionally work non-traditional work times to support remote audits in other time zones Ability to travel up to 10% of the time to perform on-site audits Proven strong leadership, collaboration and influencing skills, with demonstrated ability to problem solve and drive positive change. Motivated and organized critical thinker with solid interpersonal and business communication skills The desire and ability to work in a fast-paced, start-up environment The salary range for this position is $124,000 - 150,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell’s compensation practices and an applicant’s qualifications and experience. Employees are also eligible to participate in Lyell’s Equity Incentive Plan. Our Employee Benefits program is extensive and includes subsidized medical, dental and vision plans from your first day of employment, FSA, Company provided Life and AD&D Insurance as well as STD and LTD Insurance, ESPP, a 401(k) Plan with Company match, mass transit commuter benefits, cell phone reimbursement and a range of supplemental benefits that you may choose to elect. Our paid time-off benefits currently include flexible time off, 8 observed holidays as well as a floating holiday. We also have a winter office shutdown. At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.

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