Director, Clinical Quality

Are you passionate about advancing clinical research in cutting-edge biotherapeutics? Join a dynamic organisation in the life sciences sector where you will play a vital role in shaping the future of patient-centered therapies. This is a fantastic opportunity to bring your expertise to a team committed to innovative treatments and global impact, with the added benefit of a competitive compensation package.

Our client is a leading organisation supporting drug development initiatives within the biotherapeutics and oncology space. They focus on delivering advanced cellular therapies and innovative treatment solutions that aim to transform patient outcomes. As part of their team, you will be instrumental in ensuring the highest standards of clinical quality and compliance across their broad portfolio of clinical programs.

Role Summary
You will serve as the Director of Clinical Quality Assurance, providing strategic leadership to establish and oversee the company's Clinical QA function. You will work closely with cross-functional teams to ensure all clinical activities uphold global regulatory standards, including FDA, EMA, and ICH guidelines. This role offers a unique chance to influence clinical development processes directly, safeguarding patient safety and data integrity throughout the lifecycle of the company's innovative therapies. The position is on-site in Raleigh, NC, with occasional travel.

Key Responsibilities

• Lead the development and execution of comprehensive Clinical QA strategies aligned with company goals.
• Manage GCP compliance and oversee clinical monitoring, data management, and pharmacovigilance activities.
• Develop inspection readiness plans and ensure clinical studies are prepared for regulatory audits.
• Drive risk-based quality planning and implement continuous improvement initiatives.
• Oversee vendor qualifications, audits, and CAPAs to maintain high-quality standards.
• Collaborate with teams to embed quality principles into regulatory and clinical deliverables.
• Provide training and guidance on GCP regulations and QA procedures across teams.
• Facilitate internal audits and review clinical compliance via risk-informed strategies.
• Monitor KPIs, review adverse trends, and implement corrective actions as needed.
• Support regulatory submissions, including IND, CTA, and BLA/MAA, ensuring quality and compliance.

Experience & Requirements

• Bachelor’s or master’s degree in a life science discipline or related field.
• Minimum of 12 years in GCP, pharmacovigilance, and QA within the biopharma industry.
• Over 8 years of supervisory experience managing clinical quality teams.
• Extensive experience with clinical trials in biological therapies and oncology, particularly CAR-T and hemato-oncology.
• Knowledge of regulatory requirements for cell/gene therapies, including US and European standards.
• Strong project management, leadership, and communication skills.
• Fluency in English; bilingual in French and English is preferred.

Compensation
This role offers a base salary between $225,000 and $250,000.

Join a team that’s making a difference in life sciences and contribute to groundbreaking therapies. Apply now to be part of a growing organization shaping the future of cellular medicine and oncology treatments.

Note: When you apply, a real person from our team will review your details and reach out. We believe in transparency, fairness, and human connection in everything we do.