Director, Clinical QA
About the Company
Our client is a growing, research-driven biopharmaceutical organization focused on advancing innovative therapies in areas of high unmet medical need. With a strong pipeline and global clinical development footprint, the company is committed to maintaining the highest standards of patient safety, regulatory compliance, and clinical quality throughout the development process. This opportunity offers the chance to play a critical role in shaping Clinical Quality strategy while partnering with cross-functional teams across a complex and evolving clinical portfolio.
Position Summary
Our client is seeking an experienced Director, Clinical Quality Assurance to lead Clinical Quality activities supporting global clinical development programs. This individual will be responsible for driving Clinical Quality strategy, overseeing GCP compliance, managing audits and inspections, and ensuring clinical programs are conducted in accordance with internal procedures and global regulatory requirements.
The successful candidate will serve as a key quality leader, providing strategic oversight of clinical quality systems, inspection readiness initiatives, and risk-based quality management activities while partnering closely with Clinical Operations, Development, Regulatory Affairs, and external partners.
Key Responsibilities
- Lead the development and execution of Clinical Quality Assurance strategy across clinical development programs.
- Conduct and oversee GCP audits of investigator sites, vendors, clinical systems, study documentation, and internal processes.
- Lead inspection readiness activities and support regulatory authority inspections globally.
- Provide oversight of clinical quality systems and drive continuous improvement initiatives.
- Assess clinical compliance risks and implement risk-based quality management approaches.
- Partner with Clinical Operations and study teams to ensure adherence to GCP regulations and company procedures.
- Review audit findings, identify compliance trends, and drive corrective and preventive actions.
- Serve as a strategic quality advisor to senior leadership and clinical stakeholders.
- Support vendor qualification, oversight, and clinical compliance programs.
- Mentor and develop quality personnel while helping build organizational quality capabilities.
Qualifications
- Bachelor's degree in Life Sciences, Clinical Research, Pharmacy, Nursing, or a related discipline; advanced degree preferred.
- 12+ years of experience within Clinical Research, Clinical Operations, Clinical Quality, or related GxP environments.
- 5+ years of direct GCP auditing experience.
- Strong experience leading regulatory inspections and inspection readiness activities.
- Deep knowledge of GCP regulations, ICH guidelines, FDA regulations, EU clinical trial requirements, and international regulatory standards.
- Experience auditing clinical sites, CROs, vendors, and internal quality systems.
- Strong understanding of quality systems, risk management, CAPA, and compliance programs.
- Experience interacting with senior stakeholders and influencing cross-functional decision-making.
- Knowledge of clinical data integrity, computerized systems, and quality oversight principles.
Why Join?
This is a highly visible leadership opportunity within a growing clinical development organization where quality plays a strategic role in business success. The successful candidate will have the opportunity to shape Clinical Quality strategy, lead global inspection readiness efforts, partner directly with executive leadership, and support innovative therapies through all phases of development. The role offers significant exposure to global clinical operations, regulatory interactions, vendor oversight, and quality leadership activities while providing a path for continued advancement within Clinical Quality and Compliance leadership.
FAQs
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