Senior Manager, Quality Assurance

Role Summary

As the Sr. Manager GCP Clinical Quality reporting to the Senior Director GCP Quality, you will be partnering 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 as well as reviewing / approving study-related documents and plans and supporting audits.

This hybrid role is based out of either our San Francisco, CA or Cambridge, MA office and will require up to 20% travel.

Responsibilities

• Assist in preparation for, and support of health authority inspections
• Supporting the training of cross-functional teams on inspection expectations and processes
• Verifying the completeness, accuracy, and availability of inspection-ready documentation
• Contributing to the development of inspection storyboards and key messaging
• Facilitating and participating in mock inspection activities
• Serving 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 any findings/observations, including corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders
• Oversee quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP
• Oversee clinical compliance and quality within the context of cross-functional study teams
• Continue to improve/refine Olema’s risk based GCP compliance approach globally
• Support Quality Management System (QMS) including, but not be limited to: QA review/approval of deviations, CAPAs and change controls
• Draft, review, and approve policies, procedures and work instructions

Qualifications

• 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.)
• Required: Minimum 7 years of relevant experience in Quality Assurance or related role in a pharmaceutical/biotechnology environment
• Required: Demonstrated experience leading/internal/external QA audits and risk-based audit planning
• Required: Ability to develop and foster positive relationships with internal staff and external vendors
• Required: Experience preparing for/regulatory inspections (primarily FDA); global regulator experience a plus
• Required: Experience writing and reviewing SOPs
• Required: Experience using QMS (Veeva systems preferred)
• Required: Knowledge/experience in GCP, GVP regulations; GLP experience preferred
• Preferred: Excellent verbal and written communication skills
• Preferred: Ability to work independently and collaboratively in a fast-paced, matrixed environment
• Preferred: Analytical thinking, problem-solving, and ability to adapt to changing priorities
• Preferred: Strong planning, organization, and time management skills; ability to manage multiple projects
• Preferred: Hands-on contributor capable of operating as an individual and as part of a team

Skills

• GCP and GVP regulatory knowledge
• Quality Management System administration and CAPA handling
• Audit planning, execution, reporting, and closure
• Inspection readiness and response strategies
• Effective cross-functional collaboration and stakeholder communication

Education

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

Additional Requirements

• Up to 20% travel