Offres d'emploi Deviation & CAPA Governance Lead | Quality Investigations & Root Cause Analysis | Operational Excellence | Pharma GMP

À propos du poste Deviation & CAPA Governance Lead | Quality Investigations & Root Cause Analysis | Operational Excellence | Pharma GMP

Recrutis is supporting one of its clients, a leading biopharmaceutical manufacturer in Flanders, in the search for an NC/CAPA Governance Lead, based on site in the Flanders region (Belgium).

Why this role

  • High-visibility role moderating daily NC/CAPA governance and driving structured governance discipline across a high-volume GMP operation.
  • Direct, measurable impact on investigation quality, CAPA effectiveness and overall governance maturity.
  • Broad cross-functional leadership exposure across Operations, MSAT, QA, Engineering, GET and support functions.
  • A role that combines structured governance and analytics with genuine hands-on shopfloor engagement and coaching.

Key information

  • Location: Flanders region (Belgium) — 100% on-site presence.
  • Contract: consulting mission.
  • Start: as soon as possible.
  • Seniority: 8 to 10 years of relevant experience.
  • Languages: Dutch (Flemish) mandatory; professional English required.

Scope

  • Moderate daily NC/CAPA governance meetings and drive structured governance discussions.
  • Coordinate cross-functional stakeholders across Operations, MSAT, QA, Engineering, GET and support functions, and challenge teams where governance process, timelines or escalation discipline are not aligned.
  • Facilitate RCA discussions and RCPS workshops for complex and recurring investigations, and run recurring RCPS coaching sessions for operational teams.
  • Drive escalation follow-up, action tracking and operational accountability for NC/CAPA records, including investigation ownership and approval accountability.
  • Trend and analyse daily NC/CAPA activity, recurrence patterns, aging metrics and escalation risks.
  • Support governance reporting, dashboard visibility, KPI reviews, audit-readiness activities and documentation reviews.
  • Apply and coach Lean problem-solving methodologies (5 Why, Fishbone, Fault Tree Analysis, DMAIC, Pareto, Kaizen).

Profile — Required criteria (knockout)

  • 8 to 10 years of experience in NC/CAPA governance, Operational Excellence or GMP-regulated operations.
  • Hands-on Pharma / GMP operational experience.
  • Proven experience moderating NC/CAPA governance meetings and cross-functional operational forums.
  • Experience in RCA facilitation and RCPS coaching methodologies.
  • Strong understanding of GMP, Quality Systems and NC/CAPA lifecycle management.
  • Dutch (Flemish) speaking capability — mandatory.
  • Availability for 100% on-site presence in the Flanders region.

Strong assets — Differentiators

  • Lean Green Belt / Black Belt or RCPS certification.
  • Experience managing high-volume operational governance environments.
  • Proficiency with dashboard and reporting tools (Power BI, Tableau).
  • Familiarity with Truvault NC/CAPA documentation systems and PLM / governance reporting tools.
  • CAPA / 8D methodology expertise.

Process — Confidential recruitment process. Response within 48 hours for applications meeting required criteria. Active mandate, priority review.

Keywords — NC/CAPA, CAPA governance, RCA, RCPS, root cause analysis, Operational Excellence, Lean, GMP, Quality Systems, deviation management, 8D, Power BI, pharma manufacturing, Dutch, Flanders, Belgium

Fabrice Cattant — Founder, Recrutis | Expert & Executive Search in Life Sciences