We are seeking an experienced Senior Manager, R&D Quality Assurance to independently lead Clinical Quality Assurance (CQA) activities for assigned clinical studies. This role will serve as a QA Program Lead, providing oversight to ensure study conduct is compliant with the protocol, Good Clinical Practice (GCP), regulatory requirements, and internal procedures. The position will also lead inspection readiness and audit activities and provide support to various quality and compliance functions.
Key Responsibilities:
Program Lead (PL) Responsibilities
Inspection Readiness
Audit and Vendor Oversight
Process Quality Excellence (PQE) Support
Requirements
Required Qualifications:
Preferred Qualifications:
Benefits
Contract Terms:
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