Overview:

QA Leader to support the quality management systems and processes for a CRO based in Burlington. Working within pharma in both biologic development and cell and gene therapy and reporting directly to the Senior Director of Global Compliance.

Role Responsibilities:

• Shape and expand our US quality management systems.
• Lead audits, ensuring GCP/GLP compliance.
• Oversee systems, suppliers, and employee training.
• Drive continuous improvement in quality processes.
• Champion a strong quality culture within the team.
• Collaborate with clients, auditors, and internal teams.

Previous Experience:

• 5+ years QA GCP/GLP experience (biopharma/cell & gene therapy a plus)
• Passion for quality and cultural change leadership
• Regulatory auditing experience
• Excellent communication, teamwork, and leadership skills
• Experience leading/participating in regulatory GCP/GLP audits