Senior GCP QA Consultant

Salary $140/HR - $200/HR
LocationSouth San Francisco, California
Employment type Contract
Discipline
Life Sciences

Job description

Position Summary – GCP Quality Assurance Lead

We’re seeking an experienced GCP Quality Assurance professional to provide strategic and operational leadership across all aspects of clinical QA. This role will ensure high standards of GCP compliance, patient safety, and data integrity from early development through regulatory submissions. The ideal candidate will bring strong expertise in global GCP regulations, quality systems, and audit management, with proven success in both in-house and outsourced environments.

Key Responsibilities

  • Develop and implement regulatory and clinical QA strategies across clinical programs.

  • Lead creation, revision, and training of SOPs and QA processes to ensure GCP compliance.

  • Serve as QA representative on clinical study teams; review and approve essential study documents (protocols, ICFs, etc.).

  • Oversee inspection readiness activities, lead regulatory inspections and partner audits, including those at CROs and vendors.

  • Evaluate and qualify GCP vendors; lead or manage vendor audits and site audits (routine and for-cause).

  • Design and execute clinical audit plans and perform TMF and CSR reviews.

  • Investigate quality issues, manage CAPAs, and track key quality metrics.

  • Help build and improve a fit-for-purpose QMS for early- and late-stage development.

  • Stay current on GCP and global regulatory requirements (FDA, EMA, MHRA, PMDA).

  • Lead cross-functional initiatives to drive quality improvement and risk mitigation.

Qualifications

  • BS/MS in a scientific or related discipline; advanced degree preferred.

  • 10–12+ years’ experience in clinical quality assurance, including strong sponsor oversight and vendor management.

  • Minimum 5 years’ experience working in an outsourced (CRO) model.

  • Proven inspection experience with FDA, EMA, MHRA, and/or PMDA.

  • Strong understanding of ICH GCP, GLP, FDA/EU regulations, and Part 11 compliance.

  • Demonstrated leadership, communication, and project management capabilities.

  • Experience with EDMS and audit certifications (e.g., RQAP-GCP) strongly preferred.

  • Willingness to travel domestically and internationally (10–30%).