Senior Manager, GCP Quality Assurance

Role Summary

Senior Manager, GCP Clinical Quality, reporting to the Senior Director GCP Quality. Partners with Clinical Development/Operations, Pharmacovigilance and Safety to participate in cross-functional study teams to ensure GCP/GVP compliance, identify and communicate trial-related risks, and support audits. Hybrid role 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 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
• Provide GCP/GVP auditing activities, including preparation, execution, reporting, and CAPA follow-up
• Communicate audit results to internal stakeholders
• Oversee quality aspects of clinical study start-up, execution, and close-out, providing leadership and direction
• Oversee clinical compliance and quality within cross-functional study teams
• Improve/refine risk-based GCP compliance approach globally
• Support Quality Management System (QMS) activities, including 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 industry quality management tools and quality systems (QMS, eTMF, EMRs, EDC, etc.)
• Experience:
  • Minimum 7 years of relevant experience in Quality Assurance or related role in pharmaceutical/biotech environment
  • Experience leading/conducting internal and external QA audits with risk-based plans
  • Ability to develop positive relationships with internal staff and external vendors
  • Experience preparing for/regulatory inspections (primarily FDA); other global agencies a plus
  • Experience writing/reviewing SOPs
  • Experience using QMS (Veeva preferred)
  • Knowledge/experience in GCP/GVP; GLP experience preferred

Skills

• Excellent verbal and written communication
• Ability to work independently and collaboratively in a fast-paced, matrixed environment
• Analytical, problem-solving, and adaptability to changing priorities
• Strong planning, organization, and time management for multiple projects
• Hands-on, proactive individual contributor

Education

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

Additional Requirements

• Travel up to 20% of the time