Senior Manager, GCP Quality Assurance

Role Summary

Senior Manager, GCP Clinical Quality, reporting to the Senior Director GCP Quality. Partner with Clinical Development/Operations, Pharmacovigilance and Safety to participate in cross-functional study teams ensuring GCP/GVP compliance, assist in identifying and communicating clinical trial risks and opportunities for process improvement, review/approve study-related documents and plans, and support audits. This hybrid role is based in San Francisco, CA or Cambridge, MA, with up to 20% travel.

Responsibilities

• Assist in preparation for, and support of health authority inspections
• Support training of cross-functional teams on inspection expectations and processes
• Verify completeness, accuracy, and availability of inspection-ready documentation
• Contribute to the development of inspection storyboards and key messaging
• Facilitate and participate in mock inspection activities
• Serve in front-room and back-room roles as required during inspections
• Perform internal and external audits to ensure compliance with GCP/GVP regulations and guidelines
• Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and CAPA follow-up; communicate audit results to internal stakeholders
• Oversee quality aspects of clinical study start-up, execution, and close-out; provide leadership and direction to staff consistent with GCP/GVP
• Oversee clinical compliance and quality within cross-functional study teams
• Continuously improve Olema’s risk-based GCP compliance approach globally
• Support Quality Management System (QMS) activities including QA review/approval of deviations, CAPAs, and change controls
• Draft, review, and approve policies, procedures, and work instructions

Qualifications

• Knowledge — Bachelor’s degree required; advanced degree (MS, PharmD, PhD) preferred; strong understanding of clinical trials and pharmacovigilance reporting; strong understanding of FDA, EMA, and ICH health compliance requirements; understanding of quality management tools and systems (QMS, eTMF, EMRs, EDC, etc.)
• Experience — Minimum 7 years in Quality Assurance or related role in pharmaceutical/biotechnology; experience leading internal/external QA audits and risk-based audit plans; ability to foster cross-functional relationships with internal staff and external vendors; experience preparing for/regulatory inspections (FDA and others); experience writing/reviewing SOPs; experience using QMS (Veeva preferred); knowledge of GCP and GVP; GLP experience preferred
• Attributes — Excellent verbal and written communication; ability to work independently and collaboratively in a fast-paced, matrixed environment; analytical, problem-solving mindset; strong planning, organization, and time management; hands-on contributor

Education

• Bachelor’s degree required; advanced degree (MS, PharmD, PhD) preferred

Additional Requirements

• Travel up to 20% as part of role