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Manager/Senior Manager, Supplier Quality
1 month ago
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 External Quality, which includes SQM and CMO quality oversight, and will work cross-functionally to execute and improve the processes.
Responsibilities (include but are not limited to):
• Manage, track, and coordinate supplier qualification activities, ensuring they are completed on time.
• Work extensively with cross-functional teams and external suppliers to manage and monitor material and service suppliers, such as supplier risk evaluation, issue resolution, and qualification rating assignment, etc.
• Review and ensure supplier files and databases are current and accurate.
• Perform quality agreement periodic reviews and revise/negotiate quality agreement.
• Support management of supplier change notifications and investigations.
• Identify and mitigate risks associated with the suppliers and/ or escalate to management.
• Participate in departmental and cross-functional process improvement initiatives and special projects as identified by management to support the business need.
• Other duties as assigned based on capability and experience, including but not limited to CMO quality oversight activities, such as supporting batch disposition by reviewing executed batch-related documentation and ensure proper resolution of quality issues, management of change controls, etc.
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 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 and duties 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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