FREELANCE Departmental Compliance Lead (DCL) – GMP / Quality Transformation
Senior Equipment Qualification / Validation Specialist – Lead Compliance Transformation
📍 Flemish region Belgium | 💼 Freelance Contract only | 🌍 Dutch Language requirement
🔎 Role Overview
We are looking for a FREELANCER - Departmental Compliance Lead (DCL) with a strong background as a Senior Equipment Qualification / Validation Specialist to play a key role in driving compliance excellence and quality mindset transformation within a GMP-regulated environment.
This position is part of a strategic compliance uplift program, where the DCL acts as a change agent to strengthen and elevate the broader compliance landscape across the department.
You will act as a bridge between QA, operations, and senior leadership, ensuring that System-Based Compliance (SBC) processes are not only maintained, but actively improved to meet GxP, data integrity, and regulatory expectations.
🎯 Key Responsibilities
🔹 Compliance Ownership & Continuous Improvement
* Maintain a clear, up-to-date overview of departmental quality & compliance processes and their interdependencies
* Ensure alignment with GxP, data integrity standards, and regulatory requirements
* Monitor and improve SBC (sub)element performance metrics
* Identify gaps and drive continuous improvement initiatives across processes
* Support and coach LPOs, enabling high-quality execution and compliance ownership
* Act as an escalation point and remove barriers to ensure successful execution
🔹 Driving Quality Mindset & Standards
* Act as a key driver in uplifting the quality mindset across teams
* Define, set, and reinforce high standards for compliance and execution
* Promote a culture of data integrity, right-first-time, and accountability
* Support teams in understanding and applying quality principles in daily operations
* Act as a role model and ambassador for compliance excellence
🔹 Inspection Readiness & Risk Management
* Act as first point of contact for inspection readiness within the department
* Lead and coordinate inspection preparation and readiness activities
* Represent the department during regulatory inspections and walkthroughs
* Maintain and manage the departmental risk register
* Escalate compliance risks and gaps to site leadership in a timely manner
🔹 Procedures, Training & Governance
* Ensure consistency in SOPs, work instructions, and training materials
* Drive standardization and best practice sharing across departments
* Collaborate closely with QA, compliance leadership, and senior stakeholders
* Support CAPAs, audits, remediation plans, and global compliance initiatives
⚙️ Key Requirement – Equipment Qualification Expertise
We are specifically looking for a senior equipment/validation specialist with strong quality focus, including:
* Extensive experience in equipment qualification (IQ/OQ/PQ)
* Strong understanding of validation lifecycle and GMP equipment standards
* Ability to assess, challenge, and improve qualification processes and documentation
👉 This expertise is essential, as the DCL will play a central role in uplifting compliance standards and improving validation and qualification practices across the department.
👤 Candidate Profile
* Proven experience in a GMP-regulated environment (pharma, biotech, or similar)
* Strong background in QA, compliance, validation, or equipment qualification
* Experience with data integrity and quality systems
* A hands-on, quality-driven mindset with the ability to raise standards and improve processes
* Strong communicator who can influence teams and drive change
* Fluency in Dutch and English is required
🌟 Why Join?
* Be part of a high-impact compliance transformation program
* Play a key role in driving quality culture and inspection readiness
* Work in an international, cross-functional environment
* Opportunity to set the tone and elevate standards across teams
💡 What Makes This Role Unique
This is not a standard compliance role, you will act as a true change agent, helping to:
* Drive and embed a strong quality mindset across the organization
* Improve data integrity, compliance standards, and ways of working
* Elevate equipment qualification and validation practices
* Influence both operational execution and strategic compliance direction
We encourage applications from all qualified candidates and do not discriminate based on age, gender, or any other protected characteristic.
Due to the high volume of applications, we may not be able to respond to each applicant individually.