Senior Manager, GCP Quality Assurance

Senior Manager, GCP Clinical Quality (Hybrid)

Responsibilities:
- Perform internal/external audits to ensure compliance with GCP/GVP regulations and guidelines.
- Conduct GCP/GVP audit activities (prep, execution, report writing, and follow-up), including CAPAs; communicate results to stakeholders.
- Support regulatory authority inspections and assist with GxP inspection readiness.
- Lead quality oversight for clinical study start-up, execution, and close-out in line with GCP/GVP.
- Assist in preparation for health authority inspections, suppliers, and/or clinical sites.
- Oversee clinical compliance and quality within cross-functional study teams.
- Improve/refine a risk-based GCP compliance approach globally.
- Support Quality Management System (QMS), including QA review/approval of deviations, CAPAs, and change controls.
- Draft, review, and approve policies, procedures, and work instructions.

Qualifications / Required:
- Bachelor’s degree in a scientific discipline.
- 8+ years in Quality Assurance or related role in pharma/biotech.
- Strong understanding of clinical trials and pharmacovigilance reporting.
- Strong understanding of FDA/EMA/ICH Health compliance requirements.
- Experience leading/conducting internal and external QA audits using risk-based audit plans.
- Experience supporting regulatory agency inspections; writing/reviewing SOPs.
- Knowledge of GCP and GVP (preferred: GLP).
- Experience with QMS (Veeva preferred).

Skills / Attributes:
- Excellent verbal/written communication; strong independent and collaborative work in a matrix environment.
- Analytical/problem-solving skills; ability to adapt to changing priorities.
- Strong planning/organization/time management.

Compensation:
- Base pay range: $160,000–$180,000 annually, plus equity/bonus/benefits.

Application instructions:
- None provided.