Quality Change Control Specialist

Position Overview

We are seeking a Change Control Specialist to support regulated pharmaceutical manufacturing operations by managing change control activities in compliance with cGMP and global regulatory standards. The role will partner closely with Quality, Manufacturing, Validation, and Engineering teams to ensure changes are assessed, implemented, and closed effectively.

Key Responsibilities

• Manage the complete change control lifecycle, including initiation, impact assessment, approval, implementation, and closure
• Conduct cross-functional impact assessments across quality, manufacturing, validation, and regulatory areas
• Ensure compliance with cGMP requirements and FDA regulations, including 21 CFR Parts 210 and 211
• Maintain accurate and inspection-ready documentation within electronic quality systems
• Support internal, customer, and regulatory audits related to change management

Qualifications & Experience

• 3–7 years of experience in pharmaceutical manufacturing or CDMO environments
• Hands-on experience managing change controls within regulated quality systems
• Working knowledge of cGMP and FDA 21 CFR 210/211 regulations
• Experience with electronic QMS platforms such as TrackWise, Veeva, or equivalent
• Strong documentation, coordination, and compliance orientation