Change Control Specialist
Change Control Specialist
Location: Belgium (Primarily Remote)
Contract: Freelance Consultant
Industry: Pharmaceutical & BiotechnologyOverview
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
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