Our Client, a Clinical-Stage Biotechnology company, is looking for a Manager, Supply Quality Management for their Newark, CA location.
Responsibilities:
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
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:
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
Bachelor's degree in engineering, Chemistry or Biological Sciences required
Prior experience in quality assurance/SQM, manufacturing, QC or quality engineering