QA CSV Lead (PAS-X implementation project)
Location: Belgium (40 minutes east of Antwerp)
Contract: 6-12 months
Overview
We are seeking a senior QA-CSV professional to provide strategic quality and validation leadership for the implementation of the Next Generation Manufacturing (NGM) PAS|X platform at one of our client's Belgian sites.
As the primary QA representative for Computer System Validation within the programme, you will ensure that GxP compliance, Data Integrity, validation lifecycle controls and risk-based validation principles are embedded throughout all phases of the project. You will collaborate with cross-functional stakeholders including Manufacturing, Engineering, Automation, IT, Digital and global programme teams to support a successful multi-wave deployment.
This role is focused on governance, validation strategy and deployment readiness rather than day-to-day validation execution.
Key Responsibilities
Quality and Validation Leadership
- Lead QA-CSV activities for the NGM PAS|X implementation programme.
- Develop and maintain the validation strategy covering PAS|X, associated infrastructure, interfaces and automation integrations.
- Ensure compliance with GxP regulations, company standards, GAMP 5 principles and Data Integrity requirements.
- Provide quality oversight from project initiation through go-live and operational handover.
- Maintain a risk-based validation approach and maximise the use of global templates and validated platform components.
- Review and approve validation lifecycle documentation.
Quality Governance
- Represent QA-CSV within programme governance and decision-making forums.
- Act as the quality authority for validation and compliance decisions.
- Provide quality input for project risks, deployment readiness decisions and deviation management activities.
- Escalate compliance risks when required.
- Ensure alignment with global programme standards and site expectations.
Data Integrity Oversight
- Embed Data Integrity requirements into system design, validation and operational controls.
- Ensure appropriate governance of audit trails, electronic records, electronic signatures, access management and security controls.
- Evaluate Data Integrity impact during changes, deviations and deployment decisions.
- Collaborate with Data Integrity stakeholders across the organisation.
Testing and Deployment Readiness
- Oversee qualification and validation testing activities.
- Ensure testing follows approved validation methodologies and risk-based principles.
- Review evidence packages, defect management activities and deviation assessments.
- Participate in deployment readiness reviews and go-live approval activities.
- Verify completion of validation deliverables prior to production release.
Inspection and Audit Readiness
- Prepare the programme for internal audits and regulatory inspections.
- Act as the subject matter expert for CSV and MES validation topics.
- Maintain inspection-ready validation documentation and decision records.
- Support audit responses and inspection activities.
Stakeholder Leadership
- Serve as the primary QA-CSV contact for programme leadership and functional teams.
- Advise stakeholders on compliance expectations and validation strategy.
- Drive alignment between project objectives and quality requirements.
- Mentor validation resources and promote pragmatic, inspection-ready validation practices.
Requirements
Education
- Bachelor's or Master's degree in Engineering, Computer Science, Pharmacy, Biotechnology, Life Sciences or a related discipline.
Experience
- Minimum 10 years of CSV experience in a GxP-regulated industry.
- Minimum 5 years in a QA-CSV leadership or validation governance role.
- Experience with MES, manufacturing systems or automation-integrated platforms.
- Proven involvement in large-scale digital transformation or system implementation projects.
- Strong audit and inspection readiness experience.
Technical Expertise
- GAMP 5 methodologies.
- EU GMP Annex 11.
- 21 CFR Part 11.
- Data Integrity principles.
- Validation lifecycle management.
- Change control, deviation management and CAPA processes.
- Infrastructure, interfaces, security and access control validation.
Ideal Candidate Profile
A highly credible QA-CSV leader with extensive pharmaceutical manufacturing systems experience and a proven track record supporting large-scale MES implementations. The successful candidate combines strong compliance expertise with practical programme leadership, enabling them to establish validation strategy, influence senior stakeholders and ensure deployment readiness throughout a complex multi-year PAS|X transformation programme. They are confident operating in matrix environments and are recognised as a trusted authority in GxP compliance, Data Integrity and Computer System Validation.
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