Change Controller – Global Change Management

About the role

Novintix is seeking a detail‑oriented Change Controller to lead the development, implementation, and maintenance of global change control processes within regulated pharmaceutical and life‑sciences environments. The role ensures regulatory compliance, operational efficiency, and audit readiness by coordinating cross‑functional change activities and maintaining accurate documentation.

Key responsibilities

• Prepare comprehensive change control documentation, defining scope, risk assessments, impacted functions, and stakeholder involvement.
• Develop and maintain change control plans aligned with regulatory requirements and internal quality standards.
• Organise and facilitate pre‑change alignment meetings and prepare materials for Change Control Board (CCB) reviews.
• Coordinate assessors, reviewers, and approvers to ensure timely initiation and execution of changes.
• Collaborate with Quality Assurance, Procurement, Planning, R&D, Manufacturing, and Supply Chain to support successful implementation.
• Monitor progress, manage reminders, amendments, and extensions while ensuring compliance.
• Maintain complete documentation and traceability to support internal, customer, and regulatory audits.
• Ensure all activities comply with GMP, GxP, FDA, EMA, MDR, and organizational quality management requirements.

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.
• Hands‑on experience with Windchill, Agile PLM, or similar change management systems.
• Strong understanding of GMP, GxP, FDA, EMA, MDR, and related regulatory frameworks.
• Excellent documentation, communication, coordination, and stakeholder‑management skills.
• Ability to manage multiple change requests while ensuring timely execution and compliance.

Required skills

• Windchill
• Agile PLM
• Change Control
• QMS
• GMP
• GxP
• FDA
• EMA
• MDR
• Risk Assessment
• Documentation Management