Senior QA-CSV Program Lead

QA-CSV Program Lead

Location: Beerse, Belgium

Working mode: Hybrid (3 days per week on-site and 2 WFH)

Duration: Contract initially running until the end of 2026 (opportunity for a contract extension)

Hours: Full Time, 40 hours per week

Imagine your next project leading Quality Assurance and Computer System Validation for a high-impact, strategic MES deployment at an iconic global healthcare company, driving compliance and validation governance across a multi-year, multi-wave manufacturing transformation.

This profile is a project-facing QA-CSV lead role with clear accountability for validation governance, quality decision-making, and deployment readiness, rather than a generic operational CSV support role. The role supports the NGM PAS|X Beerse Deployment Program (Project: Beerse NGM PAS|X Implementation, Planisware ID: JSC-0101874), serving as an experienced QA-CSV support lead / project QA-CSV lead.

The QA-CSV Lead is responsible for providing Quality Assurance and Computer System Validation leadership for the implementation of the Next Generation Manufacturing (NGM) PAS|X platform at the Beerse site. The role ensures that CSV, GxP compliance, Data Integrity expectations, quality risk management, and lifecycle requirements are embedded throughout the project lifecycle.

The individual serves as the main QA-CSV representative within the project and partners with Digital, IT, Manufacturing, Engineering, Automation, Quality Operations, and Global NGM stakeholders. The role is focused on validation strategy, project quality governance, deployment readiness, and inspection readiness across a multi-year, multi-wave deployment program.

Project Context includes:

• Replacement of the current Beerse system landscape with the global NGM PAS|X standard solution.

• Strategic enabler for the Transcend program and broader Beerse digital manufacturing evolution.

• Multi-year deployment with phased go-live waves across manufacturing and packaging areas.

• Interface alignment with Europe2, automation integration activities, and local deployment requirements.

• Use of global program deliverables, prior site lessons learned, and Deployment Excellence recommendations where applicable.

roles and responsibilities

• Act as QA-CSV Lead for the NGM PAS|X implementation program at Beerse.

• Define, implement, and maintain the validation strategy for PAS|X, supporting infrastructure, interfaces, automation integrations, and connected GxP manufacturing systems.

• Ensure compliance with applicable GxP requirements, company CSV standards, GAMP 5 expectations, EU GMP Annex 11, 21 CFR Part 11, and Data Integrity principles throughout the system lifecycle.

• Provide QA oversight during project initiation, design, configuration, testing, deployment, go-live, hypercare, and operational handover phases.

• Establish and defend a risk-based validation approach, including appropriate leverage of global NGM templates, prior validation evidence, and already validated standard platform components.

• Review and approve key validation deliverables, including Validation Plans, URS/FRS/Design Specifications, Risk Assessments, Traceability Matrices, test protocols, evidence packages, Validation Summary Reports, changes, deviations, CAPAs, and lifecycle documentation.

• Represent QA-CSV within the project governance structure, core team, and relevant project decision forums.

• Serve as the primary quality authority for computerized system validation, validation compliance, and quality risk management decisions within the project scope.

• Ensure alignment with Global NGM standards, Deployment Excellence recommendations, company policies, and site quality expectations.

• Support governance for phased implementation across multiple manufacturing areas and deployment waves.

• Drive quality input for project risks, validation strategy decisions, deviations, defect impact assessments, deployment readiness, and post-go-live sustainment.

• Ensure clear escalation of quality risks that may impact compliance, release readiness, inspection readiness, or project timelines.

• Embed Data Integrity principles into validation strategy, system design reviews, risk assessments, configuration decisions, and operational handover expectations.

• Ensure validation deliverables adequately address electronic records, electronic signatures, audit trails, user access, security, interfaces, backup and recovery, and system administration controls.

• Assess Data Integrity impact as part of change management, deviation management, test defect evaluation, and deployment readiness decisions.

• Partner with site Data Integrity stakeholders to ensure project deliverables remain aligned with site and enterprise expectations.

• Treat Data Integrity as part of overall CSV and GxP compliance governance, not as a standalone ownership area for this role.

• Provide QA oversight of qualification and validation testing activities executed by project teams, vendors, or implementation partners.

• Ensure test execution is traceable, risk-based, and aligned with approved validation methodology.

• Review test evidence quality, defect resolution, deviation handling, and validation impact assessments.

• Support deployment readiness assessments and go-live decisions for project environments, qualification milestones, and implementation waves.

• Confirm that required validation deliverables are completed, reviewed, and approved prior to production deployment.

• Support controlled transition from project execution to hypercare and sustain mode.

• Prepare the project for internal audits, corporate compliance assessments, and regulatory inspection readiness expectations.

• Act as Subject Matter Expert for CSV, MES validation, Data Integrity expectations, and computerized system lifecycle management as related to the NGM PAS|X implementation.

• Ensure validation packages, traceability, and project quality decisions remain inspection-ready throughout the program lifecycle.

• Support spokespersons and quality representatives during audits or inspections where CSV or PAS|X validation topics are in scope.

• Ensure decisions, deviations, quality risks, and acceptance rationales are adequately documented and defendable.

• Act as the primary QA-CSV contact for NGM project leadership, Global NGM stakeholders, IT/Digital, Automation, Engineering, Manufacturing, Quality Operations, and validation resources.

• Provide expert guidance on validation strategy, compliance risks, regulatory expectations, and quality decision making.

• Facilitate cross-functional alignment between project delivery objectives and quality/compliance expectations.

• Mentor project team members and supporting validation resources regarding CSV and Data Integrity expectations.

• Promote pragmatic, risk-based, and inspection-ready validation practices without creating unnecessary project burden.

how to succeed

• Bachelor or Master degree in Engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or a related discipline.

• Minimum 10 years of experience in Computer System Validation within a regulated pharmaceutical, biotechnology, or medical technology environment.

• Minimum 5 years experience in a lead QA-CSV or validation governance role for large GxP implementation projects.

• Demonstrated experience with MES, manufacturing systems, automation interfaces, or shopfloor digital systems.

• Experience working in matrix project organizations with global program teams, site functions, and external implementation partners.

• Strong understanding of validation lifecycle management from concept and project phase through operational handover and sustainment.

• Technical expertise in GAMP 5 and risk-based validation approaches.

• Technical expertise in EU GMP Annex 11, 21 CFR Part 11, and applicable electronic records/electronic signatures expectations.

• Technical expertise in Data Integrity principles embedded into computerized system design, validation, and lifecycle controls.

• Technical expertise in validation of interfaces, security/access controls, audit trails, backup and recovery, infrastructure, and system administration activities.

• Technical expertise in change control, deviation management, CAPA evaluation, and validation impact assessment.

• Preferred: PAS|X experience or experience with comparable MES platforms such as Syncade, PharmaSuite, or similar systems.

• Preferred: Experience with global template deployment, validation leverage, and multi-site implementation programs.

• Preferred: Experience with pharmaceutical manufacturing, packaging, formulation, filling, or supply chain systems.

• Preferred: Experience supporting readiness for regulatory inspections or internal compliance audits involving computerized systems.

• Ability to translate project complexity into a clear, defendable, and risk-based validation strategy.

• Strong quality decision-making skills in a multi-year, multi-wave deployment environment.

• Ability to challenge constructively while keeping project execution moving.

• Inspection-ready mindset with strong attention to traceability, documentation quality, and rationale capture.

• Credibility with senior project stakeholders, operational QA, IT/Digital, Engineering, Manufacturing, and external partners.

• Pragmatic understanding of where QA-CSV ownership ends and where Operational QA/process ownership begins.

benefits

This role offers a very competitive hourly rate. This contract will run until the end of the year with an opportunity for a contract extension.

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

application process

We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email or LinkedIn InMail - you must apply direct to this advert.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.