Reports to: Senior Vice President, Technical OperationsLocation: Remote or Plymouth Meeting, PA (Hybrid)Position Summary:The Director of Clinical Quality Assurance (CQA) is responsible for developing, implementing, and maintaining the company's Clinical Quality Management System (QMS) to ensure compliance with Good Clinical Practices (GCP) regulatory requirements and industry standards. This role provides oversight of all third-party vendors involved in clinical development, including CROs, laboratories, and suppliers, ensuring adherence to Good Clinical Practice (GCP) and inspection readiness for regulatory agencies.
This role partners closely with Clinical Operations and Medical Affairs leadership to ensure clinical trial execution, oversight, and medical activities are conducted in compliance with GCP, regulatory expectations, and internal quality standards.
Specific Duties: Quality Management System
- Leads all Clinical Quality Assurance (QA) activities within the company
- Develops, implements, and maintains all clinical quality assurance systems, processes, and procedures
- Develops and tracks clinical quality metrics, approves all deviations, and develops Corrective and Preventative Actions (CAPAs)
- Lead management review meetings and ensure continuous improvement.
- Maintain inspection readiness for sponsor and regulatory inspections (FDA, EMA).
Quality Oversight of CROs and Vendors
- Qualifies and audit CROs and clinical suppliers per internal SOPs.
- Monitors CRO performance and ensures compliance with GCP and company standards.
- Reviews CRO documentation (e.g., SOPs, TMF, risk management plans) for adequacy.
Risk and Compliance
- Implements proactive risk identification and mitigation processes.
- Coordinates clinical site audits and ensure timely resolution of findings.
- Ensures compliance with ICH guidelines, FDA regulations, and Part 11 requirements.
Training and Communication
- Build and roll out QA training programs for internal staff and CRO partners.
- Serve as the primary QA contact for clinical teams and external partners.
Skills: - Established GCP QA professional
- Robust understanding of quality management systems and GxP to ensure compliance with regulatory requirements
- Excellent critical data analysis, written, and oral communication skills
- Strong experience in QA Audits of Clinical sites and Third-party organizations
- Demonstrated ability to successfully interact with regulatory health authorities at inspections as well as lead all preparation, hosting, and follow-up activities
- Ability to lead and influence cross functional employees to ensure compliance, and able to enhance team performance through strong collaboration skills
- Robust knowledge of successful delivery of a clinical study, e.g., ICH-GCP, study management, site management, monitoring, SOPs, training, etc.
Education/Experience: - BA/BS in related field with at least 10 years of Quality Assurance experience in pharmaceutical GCP operations or related quality technical role in the medical space
- Deep knowledge of international guidelines ICH-GCP as well as relevant local regulations
- Significant experience with QA review of Clinical Protocols, CAPA reports, SOPs, change control processes, deviation/investigation reports, computer systems validation, QA agreements, audit reports
- Experience utilizing QMS metrics, KPIs, and QTLs to assess risks to clinical research and drug development processes
- Demonstrated expertise in leading organizational and planning activities
