Senior Manager, GCP Quality Assurance

Senior Manager, GCP Clinical Quality (Hybrid)

Responsibilities:
- Perform internal and external audits to ensure GCP/GVP compliance.
- Manage GCP/GVP audit activities: preparation, execution, reports, follow-up, CAPAs, and communicate results.
- Support regulatory authority inspections; assist with GxP inspection readiness.
- Oversee quality for clinical study start-up, execution, and close-out (leadership and guidance aligned to 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 risk-based GCP compliance approach globally.
- Support the Quality Management System (QMS): QA review/approval of deviations, CAPAs, and change controls.
- Draft, review, and approve policies, procedures, and work instructions.

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

Skills/Attributes:
- Excellent verbal and written communication.
- Independent and collaborative in a fast-paced, matrixed environment.
- Analytical problem-solving and adaptability to changing priorities.
- Strong planning, organization, and time management.

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