Change Controller / Change Coordinator

About the role

We are seeking a detail‑oriented Change Controller to drive the development, implementation and maintenance of global change control processes within a regulated pharmaceutical and life‑sciences environment. The role ensures regulatory compliance, operational efficiency and audit readiness by coordinating cross‑functional change activities and managing documentation throughout the change lifecycle.

Key responsibilities

• Prepare comprehensive change control documentation, defining scope, impacted functions, risk assessments and stakeholder involvement.
• Develop and maintain change control plans aligned with GMP, GxP, FDA, EMA and MDR requirements.
• Organise and facilitate pre‑change alignment meetings and support Change Control Board (CCB) reviews and approvals.
• Coordinate assessors, reviewers and approvers to ensure timely initiation, execution and closure of change requests.
• Collaborate with Quality Assurance, Procurement, Planning, R&D, Manufacturing and Supply Chain to support successful implementation.
• Monitor progress, send reminders, manage amendments or extensions and maintain traceable records for internal and external audits.

Required profile

• Bachelor’s degree in Life Sciences, Engineering, Pharmacy or a related discipline.
• 3–5 years of experience in change control within the pharmaceutical, medical device or life‑sciences industry.
• Strong understanding of GMP, GxP, FDA, EMA, MDR and related regulatory frameworks.
• Excellent documentation, communication and stakeholder‑management skills.
• Ability to handle multiple change requests while ensuring timely execution and compliance.

Required skills

• Windchill
• Agile PLM
• Change Management systems
• Risk assessment
• Documentation management
• Quality Management System (QMS)