Our client is one of the 2020 Best Places to Work in San Diego, located, in the North San Diego County city of Carlsbad. With the RNA molecule as the basis of our novel drug discovery platform, we are targeting an unprecedented range of therapeutic areas. Our antisense therapies are disrupting diseases and changing their course – from the rarest of conditions, to those that impact millions of people. We currently have three commercial products and more than 40 potentially transformative medicines in our pipeline designed to treat a broad range of diseases. We are interested in bringing together individuals with different skill sets into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career. Summary: Seeking an experienced Assistant Director in Quality Assurance and Compliance with strong knowledge and expertise in Vendor Management. This candidate will also have experience with managing External vendors including Contract Manufacturing Organizations (CMO), Contract testing laboratories (CTL), Raw Materials, Components, Medical Devices, Service providers, Contract warehousing and distribution, Software and Consultants/Contractors. Experience with managing Vendor-related Discrepancies, CAPAs, Change Control, Quality Agreements and Questionnaire audits is strongly preferred. The ideal candidate will also have a strong Quality Assurance, Compliance and Systems background, GMP regulations, experience with Small molecules, Biologics, Medical Devices and/or Combination Products, and Regulatory Inspections. In addition, excellent verbal and written communications skills are required. Core competencies/Responsibilities:
- Lead management of Quality Agreement program and create, negotiate and process agreements and quality terms required for GMP vendors
- Experience with Veeva data management of vendors within Veeva or similar electronic Audit/Quality management systems
- Proficient at applying Risk Management principles to qualify and manage external vendors, generate risk reports, develop mitigation plans, and coordinate vendor improvements needed to reduce risk
- Works closely with functional areas to periodically provide applicable Vendor Performance and Quality Metrics
- Strong knowledge and/or experience with planning/coordinating and conducting Audits, including questionnaire audits, according to applicable Regulatory standards
- Experience with Discrepancy management (deviation investigations, CAPA development)
- Experience with Change Control management
- Strong critical thinking, problem solving, influencing, and intra-/ inter-company communication skills
- Ability to work independently, multi-task and adjust priorities in a dynamic environment
- B.S. in Chemistry, Chemical Engineering, or related disciplines; advance degree preferred.
- 8+ years in the life sciences industry with Quality Assurance experience and 5+ years with vendor management experience
- Experience in Quality Assurance with emphasis on compliance, process improvement, etc.
- Working knowledge of regulations, such as domestic and international GMPs
- Experience in Risk Management and Quality Systems is highly desired
- Experience in problem solving, process improvement and negotiations
- Experience and understanding of drug delivery devices and manufacturing processes is desirable
- Committed to delivering high quality results, overcoming challenges, focusing on what matters
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally
- Travel up to 10% may be required