Director, Clinical Quality Assurance

Role Summary

The Director, Clinical Quality Assurance leads and manages clinical quality systems to ensure GCP compliance across all clinical trial activities. This role partners with the clinical development organization to establish, maintain, and enhance robust risk-based clinical quality programs to support investigational products in development. It is a hands-on leadership position in a fast-paced environment, focused on building and optimizing quality systems from the ground up.

Responsibilities

• Quality Leadership & Strategy
  • Develop and implement a clinical quality assurance strategy aligned with company goals and regulatory expectations.
  • Serve as the subject matter expert (SME) in GCP and clinical compliance regulations and guidelines (e.g., FDA, EMA, ICH).
  • Provide quality oversight and guidance to cross-functional clinical teams and executive leadership.
• Audit Program
  • Design, manage, and conduct internal and external GCP audits (e.g., site audits, vendor audits, TMF audits).
  • Oversee audit findings, CAPA development, and follow-up to ensure timely resolution.
  • Collaborate with CROs, vendors, and clinical sites to ensure quality expectations are met.
• Inspection Readiness
  • Lead clinical inspection readiness activities for regulatory agency inspections.
  • Serve as the CQA representative during inspections, ensuring timely and accurate responses.
• SOP & Quality System Development
  • Establish and maintain GCP-related SOPs, policies, and quality management systems.
  • Ensure continuous improvement of quality systems, procedures, and training programs.
• Training & Compliance
  • Provide GCP training and ongoing education to clinical and cross-functional staff.
  • Monitor compliance metrics and identify trends and areas for improvement.
• Collaboration & Communication
  • Act as the liaison between QA and clinical operations, regulatory affairs, and senior leadership.
  • Partner with external stakeholders (e.g., CROs, vendors) to ensure alignment on quality standards.

Qualifications

• BA/BSc in a scientific field with a minimum of 15 years’ experience; or MBA or MSc with a minimum of 10 years’ experience
• 10 years of progressive responsibility in Quality Assurance in the Biotechnology industry with at least 5 years’ experience in a management or leadership role
• Recognized subject matter expert in GCP, GVP, and GCLP and clinical quality systems
• Demonstrated ability to drive change within organizations

Knowledge, Skills and Abilities

• Demonstrated expert knowledge of FDA regulations, and ICH GCP guidelines; familiarity with EMA and MHRA regulations
• Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and interpersonal skills
• Experience managing audits and supporting regulatory inspections
• Strong knowledge of clinical trial processes; oncology and/or cell therapy a plus
• Ability to work independently and collaboratively among cross-functional teams
• Ability to work efficiently, prioritize workflows, meet deadlines, and balance competing priorities