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Supply Quality Management Manager

Temporary

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.
Responsibilities (include but are not limited to):
  • 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
Skills:
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.
About Client:
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.

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We offer competitive compensation and comprehensive benefits including medical dental vision and retirement options.

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Required Experience:

Manager

Vacancy posted 6 days ago
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