Change Control Specialist

Change Control Specialist

Location: Belgium (Primarily Remote)
Contract: Freelance Consultant
Industry: Pharmaceutical & Biotechnology

Overview

We are supporting a global biopharmaceutical organisation seeking an experienced Change Control Specialist to support international change management, quality, and lifecycle management activities. This opportunity offers the chance to work within a highly collaborative environment, coordinating change controls, supporting technology transfer initiatives, and driving process improvements across multiple global stakeholders.

• Manage and coordinate change controls within a GMP-regulated environment.
• Support global change management activities across manufacturing operations.
• Facilitate change justifications, risk assessments, and implementation planning.
• Support technology transfer, lifecycle management, and continuous improvement initiatives.
• Collaborate with Quality, Manufacturing, Supply Chain, Planning, Technical Operations, and R&D teams.
• Prepare and review technical documentation, business cases, and change records.
• Ensure compliance with GMP and quality requirements throughout the change lifecycle.
• Monitor, track, and support the timely closure of change controls.
• Coordinate activities across multiple sites and external partners.
• Drive stakeholder engagement and support operational excellence initiatives.

Typical Areas of Expertise

• Change Control
• Quality Management Systems (QMS)
• GMP Compliance
• Technology Transfer
• Technical Writing
• Documentation Management
• Risk Assessment
• CAPA Management
• Deviation Management
• Lifecycle Management
• Process Improvement
• Stakeholder Management
• Project Coordination
• Cross-Functional Collaboration
• Continuous Improvement
• Manufacturing Quality

Requirements

• Bachelor's degree in a scientific, engineering, or related discipline.
• Minimum 2 years of experience within pharmaceutical, biotechnology, biologics, or other GMP-regulated environments.
• Experience supporting Change Control, Quality Systems, CAPAs, Deviations, Investigations, or Technical Operations activities.
• Strong technical writing and documentation skills.
• Excellent communication and stakeholder management capabilities.
• Experience working within project-based, cross-functional environments.
• Ability to manage multiple priorities and work independently.
• Technology Transfer experience is highly desirable.
• Fluent English required.

Ideal Backgrounds

We are interested in professionals currently working as:

• Change Control Specialist
• Quality Systems Specialist
• QA Specialist
• Quality Engineer
• GMP Compliance Specialist
• Quality Systems Associate
• Technology Transfer Specialist
• Technical Operations Specialist
• Validation Specialist
• Manufacturing Quality Specialist
• QA Operations Specialist
• Quality Compliance Consultant
• Lifecycle Management Specialist
• GMP Project Coordinator
• Quality Systems Consultant
• Technology Transfer Specialist
• Technical Operations Specialist
• Validation Specialist
• Manufacturing Quality Specialist
• QA Operations Specialist
• Quality Compliance Consultant
• Lifecycle Management Specialist
• GMP Project Coordinator
• Quality Systems Consultant