Director, GLP/GCP/GVP Quality

The GLP/GCP/GVP Quality Director will be responsible for overseeing the quality management system (QMS) related to clinical trials and ensuring compliance with Good Laboratory Practice, (GLP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), FDA and EMA regulations, ICH guidelines, and other applicable global regulatory requirements. This is a leadership role that requires a strategic thinker who is also operational, overseeing third party vendors and audits, ensuring the integrity of data generated from clinical trials and expertise quality systems, risk management and inspection readiness. Collaborate with cross-functional teams, including Clinical Operations, Regulatory Affairs, and Clinical Development, to ensure the highest level of quality assurance across all aspects of the clinical trial lifecycle.

Key Responsibilities:

• Leadership and Strategy:
  • Lead and develop a robust quality management system, appropriate for a virtual organization, across GLP, GCP and GVP to support the Phase 3 clinical trial program and other clinical development activities.
  • Develop and implement quality strategies that align with corporate objectives, ensuring compliance with GLP/GCP/GVP standards and other relevant regulations.
• Quality Assurance and Compliance:
  • Oversee GLP, GCP, and GVP compliance for all nonclinical and clinical studies, ensuring adherence to applicable FDA, EMA, ICH, and other global regulations.
  • Develop and implement internal quality systems for GLP, GCP, and GVP, ensuring alignment with best practices and regulatory standards.
  • Build and maintain dashboards to monitor quality trends, compliance risks, audit findings, and CAPA effectiveness.
  • Provide guidance on protocol deviations, issue management, potential serious breach, and clinical documentation quality (e.g., eTMF).
• Audit Management and Inspection Readiness:
  • Oversee the GLP/GCP/GVP vendor quality management including vendor audits, inspections, and ongoing performance monitoring of CROs, labs, PV providers, clinical sites, and vendors.
  • Track audit findings, ensure timely and effective CAPA implementation, and monitor for trends. Conduct audits as necessary.
  • Lead and coordinate inspection readiness planning for pivotal Phase 3 clinical trials and support BLA/MAA submissions
• Clinical Trial Support:
  • Partner with Clinical Operations teams to ensure trial conduct is aligned with quality standards, providing guidance on GCP compliance during the trial execution phase.

Qualifications

• Education:
• Bachelor's degree in Life Sciences, Engineering, or a related field.
• Experience:
• Minimum 10 years of experience in Quality Assurance roles in biotech/pharma with a focus on GLP, GCP and GVP.
• Demonstrated experience implementing and managing a GxP-compliant QMS in a clinical-stage company.
• Experience supporting late-stage clinical trials (Phase 3), vendor oversight, and regulatory inspection highly preferred.
• Skills & Competencies:
• Expertise in FDA, EMA, ICH, and other global GxP regulation.
• Ability to collaborate with cross-functional teams and complex initiatives.
• Excellent knowledge of quality systems, documentation, and compliance management.
• Exceptional problem-solving, troubleshooting, and analytical skills.
• Strong communication and presentation skills, both written and verbal.
• Ability to work effectively in a remote, fast-paced, and evolving environment