Senior Manager, GCP Quality Assurance

Role Summary

Senior Manager, GCP Quality Assurance reporting to the Senior Director GCP Quality, partnering with Clinical Development/Operations, Pharmacovigilance and Safety to ensure GCP/GVP compliance, identify and communicate trial-related risks, review study documents, 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 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/observations, 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
• 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
• Minimum 7 years of relevant experience in Quality Assurance or related role in pharmaceutical/biotech environments
• Demonstrated experience leading and/or conducting internal and external QA audits, developing and executing risk-based audit plans
• Demonstrated 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 regulatory experience is a plus
• Experience writing and reviewing SOPs
• Experience using QMS (Veeva systems preferred)
• Knowledge and 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 skills with 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

Skills

• Strong communication (verbal and written)
• Analytical problem-solving with the ability to adapt to changing priorities
• Project planning and time management
• Independent and collaborative work style in a matrix environment

Additional Requirements

• Up to 20% travel