Sr. Consultant, Quality and Compliance

Responsibilities

• Establish and execute sponsor oversight programs for clinical trials, including CRO qualification and risk-based quality oversight
• Serve as the independent quality liaison between client sponsors and various clinical vendors
• Author and approve quality agreements, clinical vendor SOPs, and oversight plans
• Plan, conduct, and report GCP audits, including investigator sites, CROs, and TMF audits
• Lead pre-approval inspection (PAI) readiness and BIMO inspection preparation
• Author audit reports with regulatory citations and track CAPA commitments
• Review clinical trial documents (protocols, ICFs, IBs) for GCP compliance
• Oversee TMF quality, including completeness and ALCOA+ compliance
• Lead investigations into serious GCP issues such as protocol deviations and data integrity concerns
• Provide quality input on regulatory submissions (IND, NDA, BLA)
• Maintain knowledge of e...