Senior Manager, Quality Assurance

Role Summary

Senior Manager GCP Clinical Quality, reporting to the Senior Director GCP Quality, will partner with Clinical Development/Operations, Pharmacovigilance and Safety to participate in cross-functional study teams, ensure GCP/GVP compliance, identify risks and opportunities for process improvement, review and approve study-related documents, and support 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 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
• Oversee quality aspects related to clinical study start-up, execution, and close-out with leadership and direction aligned with GCP/GVP
• 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 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 quality management tools and quality systems (e.g., QMS, eTMF, EMRs, EDC)
• Experience
• Required: Minimum 7 years of relevant experience in Quality Assurance or related role in a pharmaceutical/biotech environment
• Required: Demonstrated experience leading/internal and external QA audits and risk-based audit planning
• Required: Ability to develop collaborative relationships with internal staff and external vendors
• Required: Experience preparing for regulatory inspections (FDA; global regulators a plus)
• Required: Experience writing and reviewing SOPs
• Required: Experience using QMS (Veeva systems preferred)
• Required: Knowledge of GCP and GVP regulations; GLP experience preferred
• Attributes
• Required: Excellent verbal and written communication skills
• Required: Ability to work independently and collaboratively in a fast-paced, matrixed environment
• Required: Analytical, problem-solving skills; ability to adapt to changing priorities
• Required: Strong planning, organization, and time management; ability to manage multiple projects
• Required: Hands-on contributor mindset

Skills

• Strong communication and collaboration skills
• Analytical thinker with problem-solving capabilities
• High adaptability to changing priorities and deadlines
• Proven ability to work in fast-paced, matrixed teams

Education

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

Additional Requirements

• Up to 20% travel