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
- Solid regulatory audit experience (FDA a plus)
- Excellent communication, teamwork, and leadership skills
- Experience leading/participating in regulatory GCP/GLP audits
