Job opportunity with a top biopharmaceutical company that is looking for a Senior Director R&D Quality Assurance to join their team on a 6-month contract with a good possibility for conversion or extension!
Pay Rate: $100-125/hr
Contract: Min. 6 Months
Location: San Diego, CA (Remote)
Requirements and Job Functions:
- 5-8 years of QA leadership experience; minimum 15 years pharmaceutical experience; expert knowledge
- Familiarity with Central Nervous System (CNS) therapeutic area is a big plus. of regulations; previous audit experience.
- QA lead for GCP and GVP inspections; Oversee audit program and vendors; management of QA team.
- Responsible for managing the R&D Quality Assurance activities including all R&D-related audits and associated quality system processes within the GCP, GLP, and GVP Quality Management System (QMS). The GCP, GLP, and GVP audit responsibilities include internal and external (contract service providers) functions and processes conducted within Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and applicable Computer System Validation regulations as required by all relevant regulatory agencies.
- Audit activities include all aspects of planning, execution, reporting, and procedural documentation associated with internal and external audits and resource planning necessary to conduct all audits. Scope includes external contract service providers (CSPs), clinical trial sites, and internal development teams and processes.
- Health Insurance
Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?