Responsibilities:
• Moderate daily NC/CAPA governance meetings and drive structured governance
discussions
• Coordinate cross-functional stakeholders across Operations, MSAT, QA, Engineering,
GET, and support functions
• Challenge teams where governance process, timelines, escalation discipline, or
operational follow-through are not aligned
• Drive governance discipline, escalation follow-up, action tracking, and operational
accountability activities
• Monitor stakeholder participation, governance meeting adherence, and operational
engagement
• Trend and analyze daily NC/CAPA activity, recurrence patterns, aging metrics, and
escalation risks
• Facilitate RCA discussions and RCPS workshops for complex investigations and
1recurring operational issues
• Facilitate recurring RCPS exercise coaching sessions for operational teams
• Support Lean problem-solving methodologies including 5 Why, Fishbone, Fault Tree
Analysis, DMAIC, Pareto, Kaizen…etc
• Support governance reporting, dashboard visibility, KPI reviews, and operational review
activities
• Perform hands-on operational engagement including shopfloor interaction, coaching,
observation, and governance follow-up
• Ensure governance execution aligns with GMP requirements, SOPs, and compliance
expectations
• Support operational teams in improving investigation quality and CAPA effectiveness
• Drive continuous improvement initiatives related to governance maturity and operational
excellence
• Support audit readiness activities and governance documentation reviews
• Manage investigation ownership and approval accountability for NC/CAPA records
• Complete additional governance and operational support activities assigned by
Supervisor / Manager
Qualifications Required:
• Bachelor’s degree in engineering, Life Sciences, or related technical discipline
• 8–10 years of experience in NC/CAPA governance, Operational Excellence, or GMP-
regulated operations
• Hands-on Pharma / GMP operational experience
• Experience moderating NC/CAPA governance meetings and cross-functional operational
forums
• Experience in RCA facilitation and RCPS coaching methodologies
• Lean Green Belt / Black Belt or RCPS Certification preferred
• Strong understanding of GMP, Quality Systems, and NC/CAPA lifecycle management
• Strong communication, stakeholder coordination, and escalation management capability
• Experience managing high-volume operational governance environments
• Dutch-speaking capability (Mandatory)
Skills:
• Strong governance, moderation and facilitation capability
• RCA / RCPS Methodology & Coaching
• CAPA / 8D Methodology
• Escalation Management & Operational Follow-Up
• KPI Monitoring, Trending & Governance Reporting
• NC/CAPA Lifecycle Management
• Cross-Functional Stakeholder Coordination
• Lean Problem-Solving Methodologies
• GMP & Quality Systems Knowledge
• Continuous Improvement & Operational Excellence2• Dashboard & Reporting Tools (Power BI, Tabluea..etc)
• Truvault NC/CAPA Documentation Systems
• PLM / Governance Reporting Tools
• Strong communication, analytical, and problem-solving skills
• Proficient in MS Office (Word, Excel, PowerPoint, etc.)