Manager/Senior Manager, Supplier Quality Management

3 weeks ago


South San Francisco, United States Get It Recruit - Transportation Full time

We're a dynamic biotechnology company based in South San Francisco, dedicated to pioneering advancements in cancer immunotherapy. Our mission is to develop groundbreaking allogeneic chimeric antigen receptor T cell (AlloCAR T) products to combat cancer and autoimmune diseases. Led by a passionate team with extensive experience in cell therapy, we're committed to making readily available cell therapy on-demand, more reliably, and at greater scale to benefit patients worldwide.About the Role:We're on the lookout for a highly motivated individual to join us on our journey As part of our team, you'll play a crucial role in Supplier Quality Management (SQM) program. You'll collaborate cross-functionally to execute and enhance SQ programs, contributing directly to the development of life-changing therapies.Key Responsibilities:Manage both internal and external audit programs.Ensure adherence to audit schedules and manage audit logistics efficiently.Conduct internal and external audits in line with applicable regulations and guidelines.Evaluate audit responses and determine associated risks.Review supplier compliance with regulatory standards.Oversee supplier questionnaire management, improving content and coordinating responses.Develop quality agreement templates and negotiate terms effectively.Participate in supplier qualification and monitoring activities.Contribute to process improvement initiatives and special projects as needed.Assist in developing supplier performance metrics.Perform other duties as assigned.Requirements:Bachelor’s degree in Engineering, Chemistry, or biological sciences.Preferred: Advanced degree or relevant certifications.Minimum 10 years of experience in quality assurance, manufacturing, or quality engineering.Previous experience in auditing and supplier qualification in the biopharmaceutical field.Strong understanding of quality system requirements and regulatory guidelines.Excellent communication and interpersonal skills.Ability to thrive in a fast-paced, collaborative environment.Proficiency in MS Office suite and other relevant software.Why Join Us:At our company, you'll have the opportunity to work with a talented team in an inclusive and supportive environment. We offer competitive compensation based on experience, along with the chance to make a meaningful impact on patients' lives. As an equal opportunity employer, we embrace diversity and welcome candidates from all backgrounds to join us in our mission to develop innovative therapies. Employment Type: Full-Time

Education Level: No formal educational credential

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