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Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Courcelles, Hainaut, Belgium

Job Description:

Lead Quality – Qualification & Validation (Distribution Center)
Location: Courcelles (EMEA) — Hybrid (3 days onsite / 2 days remote)
Contract: CDI / permanent contract

Join a high‑impact Quality team at a global Med Tech leader and own the technical delivery of equipment qualification & validation at a strategic European Distribution Center. This is a hands‑on, visible role where your expertise in IQ/OQ/PQ, process qualification and operational quality will directly improve patient safety, reduce regulatory risk and raise operational excellence across repack/relabel and distribution activities.

What you will do (core responsibilities)

• Lead and coordinate qualification, validation and calibration activities for equipment and facilities used in distribution and repack/relabel operations (new equipment qualification and periodic re‑qualification).

• Act as the operational Quality expert on the floor: Gemba walks, weekly operational kick‑offs and direct coaching of warehouse teams.

• Drive and follow up internal & external audits and inspections; perform proactive gap analyses and implement CAPAs to secure business continuity.

• Own Change Control activities related to DC and repackaging processes and ensure robust documentation and approvals.

• Maintain and improve QMS elements: SOPs, Work Instructions, document control, training, CAPA, investigations and KPI tracking.

• Analyze NC/CAPA and delivery service trends, propose corrective/preventive actions and feed the Quality Improvement Plan (QIP) and Quality System Management Review (QSMR).

• Participate in cross‑functional projects (new equipment, process automation), ensuring validation and regulatory requirements are met.

• Identify, assess and mitigate quality risks tied to QA and operational processes.

Who we are looking for (must‑have profile)

• Proven experience in a regulated environment (pharmaceuticals, medical devices or healthcare operations) with a clear focus on QUALIFICATION & VALIDATION of equipment and facilities.

• Demonstrated track record executing IQ/OQ/PQ protocols, preparing validation dossiers and leading equipment requalification programs.

• Strong knowledge of quality system processes: Change Control, CAPA, Investigations, Document Management, Training and Audit.

• Familiarity with GDP/GMP requirements and ISO 13485.

• Analytical mindset, risk‑based approach, excellent written & verbal communication, ability to influence cross‑functional stakeholders.

• Able to work independently, organize priorities and escalate appropriately.

Technical tools & experience (advantageous)

• Experience with JDE, ETQ (or equivalent QMS), Windchill, Summit or similar systems.

• Strong Excel and Microsoft Office skills.

• Lean/process improvement experience is valued.

Languages

• English only is sufficient to apply.

• French is a strong advantage (local interactions & documentation).

Remuneration & benefits

• Indicative base salary: €60,000 – € 96,255 gross per year (depending on experience).

• Comprehensive J&J benefits package: performance bonuses, health and pension benefits, local employee benefits (e.g., meal vouchers / mobility allowances where applicable / internet allowance /eco-cheques / leisure cheques).

• Career development and international mobility opportunities within the EMEA network.

Working arrangement

• Hybrid: 3 days onsite at Courcelles / 2 days remote per week.

• Close collaboration with Operations, Supply Chain and EMEA Deliver teams.

Why join us

• High visibility role with direct impact on compliance, safety and operational efficiency.

• Blend of technical validation work, process ownership and cross‑functional project delivery.

• Opportunity to shape best practices on Qualification and Validation processes

Required Skills: Preferred Skills: