Senior Manager, GCP Quality Assurance

Senior Manager, GCP Clinical Quality

Responsibilities (primarily):
- Perform internal and external audits to ensure compliance with GCP/GVP regulations and guidelines.
- Conduct GCP/GVP auditing: prepare, execute, and report; follow up on findings/observations; manage CAPAs; communicate results to internal stakeholders.
- Support regulatory authority inspections and assist with GxP inspection readiness.
- Oversee quality aspects of clinical study start-up, execution, and close-out, providing leadership aligned with GCP/GVP.
- Assist with 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 the Quality Management System (QMS), including QA review/approval of deviations, CAPAs, and change controls.
- Draft, review, and approve policies, procedures, and work instructions.

Requirements/Qualifications:
- Bachelor’s degree in a scientific discipline.
- Strong understanding of clinical trials and pharmacovigilance reporting; FDA, EMA, and ICH health compliance.
- Understanding of quality systems/tools (e.g., QMS, eTMF, EMRs, EDC).
- 8+ years’ relevant experience in Quality Assurance or related roles in pharma/biotech.
- Experience leading/conducting internal/external QA audits and executing risk-based audit plans.
- Experience supporting regulatory agency inspections.
- Experience writing/reviewing SOPs; QMS experience (Veeva preferred).
- GCP/GVP knowledge; preferred GLP experience.

Skills/Attributes:
- Excellent verbal and written communication.
- Collaborative, independent, matrixed team work; analytical problem-solving.
- Strong planning/organization/time management; manage multiple priorities.

Benefits:
- Base pay range: $160,000–$180,000 annually; total compensation includes equity, bonus, and benefits.

Application instructions:
- No agency resumes.