Senior Manager, GCP Quality

Role Summary

Senior Manager, GCP Clinical Quality. Partner with Clinical Development/Operations, Pharmacovigilance and Safety to ensure GCP/GVP compliance, identify and communicate clinical trial-related risks and opportunities for process improvement, review/approve study-related documents and plans, and support audits. Hybrid role based in San Francisco, CA or Cambridge, MA with 2 onsite days per week and up to 25% travel.

Responsibilities

• 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 follow-up, including CAPAs; communicate audit results to internal stakeholders
• Provide support during regulatory authority inspections and assist with GxP inspection readiness activities
• Oversee quality aspects of clinical study start-up, execution, and close-out; provide leadership and guidance to staff
• 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/refine Olema‚Äôs risk-based GCP compliance approach globally
• Support Quality Management System (QMS): QA review/approval of deviations, CAPAs, and change controls
• Draft, review, and approve policies, procedures, and work instructions

Qualifications

• Knowledge:
  • Bachelor‚Äôs degree in scientific discipline
  • Strong understanding of clinical trials and pharmacovigilance reporting
  • Strong understanding of FDA, EMA, and ICH Health compliance requirements
  • Understanding of industry quality management tools and quality systems (e.g., QMS, eTMF, EMRs, EDC)
• Experience:
  • 8+ years in Quality Assurance or related role in pharma/biotech
  • Experience leading/internal and external QA audits and risk-based audit plans
  • Ability to foster positive relationships with internal staff and external vendors
  • Experience supporting regulatory agency inspections
  • Experience writing/reviewing SOPs
  • Experience using QMS (Veeva preferred)
  • Knowledge of GCP/GVP; GLP experience preferred
• Attributes:
  • Excellent verbal and written communication
  • Ability to work independently and collaboratively in a fast-paced environment
  • Analytical thinker with strong problem-solving skills
  • Strong planning, organization, and time management; ability to manage multiple projects

Education

• Bachelor‚Äôs degree in scientific discipline

Additional Requirements

• Travel up to 25% as needed