Job Description:

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 GCPGLP 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 GCPGLP experience (biopharmacell & gene therapy a plus)Passion for quality and cultural change leadershipSolid regulatory audit experience (FDA a plus)Excellent communication, teamwork, and leadership skillsExperience leadingparticipating in regulatory GCPGLP audits