Director, Global Quality Assurance, GCP/GLP

Position: Director of Global Quality Assurance, GCP/GLP

Responsibilities
- Lead Clinical Quality Assurance (CQA) activities for assigned clinical operations and development programs, including conducting, managing, and overseeing audits, quality issues, investigations, and inspections.
- Ensure GCP/GLP oversight and compliance of studies with company SOPs, policies, and applicable global regulations/guidelines.
- Conduct oversight activities to determine compliance with internal procedures, Clinical Research Organization (CRO) procedures/regulations; provide actionable recommendations to mitigate risks/issues.
- Support study teams (e.g., attend study team meetings; analyze study health metrics; review study plans; advise on quality/compliance issues, risks, investigations, and CAPA’s).
- Conduct on-site, hybrid, and/or remote vendor or clinical site audits and inspection readiness visits.
- Establish, manage, track, and report Quality Objectives and priorities.
- Serve as the Quality Business Partner (QBP) point of contact for assigned functions.
- Manage day-to-day QA for GCP and GLP activities cross-functionally; act as quality subject matter expert for regulatory requirements/guidance.
- Provide executive-level reporting of compliance risks, trends, and audit outcomes to senior leadership/governance committees.
- Ensure rapid communication of quality issues, including potential misconduct, and significant issues to Health Authorities and senior management.
- Lead and support Health Authority inspections (sponsors and sites) and inspection readiness for assigned studies.
- Collaborate to develop/refine GCP/GLP SOPs.
- Support Quality Management System (QMS) programs (e.g., Supplier Quality Management, audits, inspection readiness).
- Monitor QA and Clinical Operations metrics and participate in cross-functional review forums (including Quality Management Review).
- Stay current on industry trends, regulations, and best practices to maintain compliance.
- Interact with third-party vendors and business partners to ensure quality compliance.

Qualifications
- Bachelor’s degree.
- 10+ years’ experience managing Quality activities related to GCP and GLP in biopharmaceutical Clinical Development and Operations.
- Extensive knowledge of Quality Assurance principles, practices, and standards.
- GCP/GLP compliance expertise, including regulatory requirements (US FDA, China, EU, ICH).
- Experience building/maintaining systems, processes, and tools for Quality oversight of GCP/GLP activities.
- Regulatory agency audit hosting experience.
- Experience leading direct reports and managing talent.

Skills / Requirements
- Ability to function as both leader and individual contributor; define and drive work independently.
- Strong decision-making balancing speed, quality, and risk under tight deadlines.
- Ability to influence functional prioritization to align with corporate objectives.
- Demonstrated effectiveness with internal/external strategic relationships.
- “One team” mindset; ability to remove barriers and enable cooperation across teams/partners.
- Flexibility for non-traditional work hours across time zones.
- Travel to and from headquarters monthly and internationally as needed (up to 25%).

Compensation / Benefits
- Eligible for a competitive compensation and benefits package.
- Base salary pay range: $166,600 to $208,261; actual compensation depends on factors including experience, education, skills, performance, and/or location.