Senior Manager, GCP Quality Assurance

About the Role Senior Manager, GCP Clinical Quality reporting to the Senior Director GCP Quality Assurance. Partner with Clinical Development/Operations, Pharmacovigilance and Safety to actively participate in cross‐functional study teams to ensure GCP/GVP compliance, identify and communicate clinical trial‑related risks, review study documents and plans, and support audits. This hybrid role is based out of our San Francisco, CA or Cambridge, MA office and requires 2 days a week on site and up to 25% travel. Responsibilities Your work will primarily encompass: Perform internal and external audits to ensure compliance with GCP/GVP regulations and guidelines Conduct audit activities, including preparation, execution, report preparation and follow‑up to findings, including CAPAs, and communicate audit results to stakeholders Support regulatory authority inspections and assist with GxP inspection readiness activities Oversee quality aspects related to clinical study start‑up, execution and close‑out, providing leadership, guidance and direction consistent 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 Continue to improve and refine Olema’s risk‑based GCP compliance approach globally Support Quality Management System (QMS), including review and approval of deviations, CAPAs and change controls Draft, review and approve policies, procedures and work instructions Ideal Candidate Profile Knowledge Bachelor’s degree in a scientific discipline Strong understanding of clinical trials and pharmacovigilance reporting Understanding of FDA, EMA and ICH health compliance requirements Familiarity with industry quality management tools and systems (e.g., QMS, eTMF, EMRs, EDC) Experience Minimum 8 years in Quality Assurance or related role in pharma, biotech or related environment Experience leading or conducting internal and external QA audits, developing risk‑based audit plans Ability to develop and foster positive, collaborative relationships with internal staff and external vendors Experience supporting regulatory agency inspections Experience writing and reviewing SOPs Experience using QMS (Veeva systems preferred) Knowledge and experience in GCP, GVP. Preferred GLP experience Attributes Excellent verbal and written communication skills Ability to work independently and collaboratively in a fast‑paced, matrixed team environment Analytical thinker with strong problem‑solving skills and adaptability to changing priorities and deadlines Excellent planning, organization, time‑management skills and ability to prioritize multiple projects Compensation Base pay range: $160,000 – $180,000 annually, varying by location, market, experience. Total compensation includes equity, bonus and benefits. Equal Opportunity We provide equal opportunity to all employees and applicants for employment and celebrate diverse backgrounds. Benefits We offer a competitive compensation and benefits package with a flexible, friendly work environment. A summary of benefits is available. #J-18808-Ljbffr Olema Pharmaceuticals, Inc.