We are looking for an experienced Associate Director to join the Clinical Quality Business Partner team of a leading Biotechnology company we work closely with. This position is located in Foster City, CA, and is offered on initial 6 month contract opportunity, with potential to extend/convert. This is an onsite opportunity, and offers a highly competitive pate and access to overtime. The chosen induvial would represent R&D Quality & Medical Governance on the global clinical study management teams advising on areas of GCP risk.
Primary Responsibilities:
- Serve as Clinical Quality Business Partner lead for assigned clinical trial programs. Handle multiple projects and ensure overall and timely completion of tasks.
- Act as Subject Matter Expert performing global risk assessment for investigator site and vendor audit planning.
- Collaborate with the Audit, Inspection and CAPA Management Team within R&D Quality & Medical Governance.
Qualifications:
- BA or BS and 10+ years of relevant experience (8+ years of relevant experience with an applicable MS).
- At least 6 years of audit and compliance experience. Must have significant GCP audit and compliance experience. Bio-pharma sponsor experience preferred.
Please apply with your most up to date resume to be considered.
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