Manager, Supply Quality Management

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. Responsible for supplier questionnaire management, including improving questionnaire content, coordination of questionnaire completion with suppliers, and evaluation of responses.

Location: Newark, CA 94560
Duration: 6 months
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 the Supplier Qualification Management (SQM) program, specifically quality agreement negotiation and management. This is a contract position working 20-25 hours per week.

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:

• Bachelor's degree in engineering, Chemistry or Biological Sciences required
• Prior experience in quality assurance/SQM, manufacturing, QC or quality engineering
• Experience in quality agreements negotiation and management 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 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
• Experience with Veeva is a plus but not required
• Candidates must be authorized to work in the US

Education:

• Bachelor's degree in engineering, Chemistry or Biological Sciences required
• Prior experience in quality assurance/SQM, manufacturing, QC or quality engineering