Senior Manager, GCP Quality Assurance

Role Summary

The Senior Manager, GCP Clinical Quality partners with Clinical Development/Operations, Pharmacovigilance and Safety to actively participate in cross-functional study teams ensuring GCP/GVP compliance, assisting in identifying and communicating clinical trial-related risks and opportunities for process improvement, reviewing and approving study-related documents and plans, and supporting audits. This hybrid role is based in San Francisco, CA or Cambridge, MA and requires up to 20% travel.

Responsibilities

• Assist in preparation for, and support of health authority inspections
• Support the training of cross-functional teams on inspection expectations and processes
• Verify the 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 as assigned to ensure compliance with GCP/GVP regulations and guidelines
• Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to findings, including CAPAs, and communicate audit results to internal stakeholders
• Oversee quality aspects related to clinical study start-up, execution, and close-out by providing leadership and direction to staff consistent with GCP/GVP
• Oversee clinical compliance and quality within cross-functional study teams
• Continue to improve/refine Olema’s risk-based GCP compliance approach globally
• Support Quality Management System (QMS) including QA review/approval of deviations, CAPAs and change controls
• Draft, review, and approve policies, procedures and work instructions

Qualifications

• Knowledge
  • Required: Bachelor's degree; advanced degree (MS, PharmD, PhD) preferred
  • Required: Strong understanding of clinical trials and pharmacovigilance reporting
  • Required: Strong understanding of FDA, EMA, and ICH health compliance requirements
  • Required: Understanding of industry quality management tools and quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.)
• Experience
  • Minimum 7 years of relevant experience in Quality Assurance or related role in a pharmaceutical/biotechnology environment
  • Demonstrated experience leading and/or conducting internal and external QA audits and developing/executing risk-based audit plans
  • Ability to develop and foster positive, collaborative relationships with internal staff and external vendors
  • Experience preparing for and supporting regulatory agency inspections, primarily FDA; additional global experience is a plus
  • Experience writing and reviewing SOPs
  • Experience using QMS (Veeva systems preferred)
  • Knowledge/experience in GCP and GVP regulations; GLP experience preferred
• Attributes
  • Excellent verbal and written communication skills
  • Ability to work independently and collaboratively in a fast-paced, matrixed environment
  • Analytical thinker with strong problem-solving skills and adaptability to changing priorities
  • Strong planning, organization, and time management; ability to manage multiple projects
  • Hands-on, capable of being a strong individual contributor

Education

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

Additional Requirements

• Travel up to 20% as part of the role