Supply Quality Management Manager
Allogene Therapeutics
Title: Supply Quality Management Manager
Location: Newark CA 94560 (Onsite)
Duration: 6 Months Contract (Potential to Extend)
Part-time Opportunity (20-25 hours per week)
Description:
- 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 specifically quality agreement negotiation and management.
- 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
- Assist in supplier qualification activities and supplier monitoring activities
- Assist in departmental and cross-functional process improvement initiatives and special projects as identified by management to support the business need
- Other duties as assigned
Requirements:
- Bachelors degree in engineering Chemistry or Biological Sciences required
- Prior experience in quality assurance/SQM manufacturing QC or quality engineering
- Experience in quality agreement negotiation and management required
- Extensive working knowledge of quality system requirements such as US FDA GMP GCP EMA and ICH guidelines and 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 and PowerPoint
- Experience with Veeva is a plus but not required
- Candidates must be authorized to work in the US without sponsorship.
Client 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. #TBL1
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Required Experience:
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