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 risks and opportunities for process improvement, review study documents, 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 CAPA follow-up; communicate audit results to internal stakeholders
• Support 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 direction to staff in line 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
• Improve/refine Olema’s risk-based GCP compliance approach globally
• Support Quality Management System (QMS) activities: QA review/approval of deviations, CAPAs, and change controls
• Draft, review, and approve policies, procedures and work instructions

Qualifications

• Knowledge:
  • Bachelor’s 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/conducting internal and external QA audits with risk-based plans
  • Ability to build 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, matrixed environment
  • Analytical problem-solver with adaptability
  • Strong planning, organization, and time management; multi-project prioritization
  • Hands-on, strong individual contributor

Education

• Bachelor’s degree in a scientific discipline