NC/CAPA Governance Moderator & RCPS Lead

About NovintiX

NovintiX is a fast-growing engineering solutions and digital transformation consultancy partnering with leading Life Sciences and MedTech organisations across Ireland, Europe, and the US. We deliver high-impact engineering services, digital transformation programmes, automation solutions, validation services, and specialist talent solutions that help regulated industries accelerate innovation, operational excellence, and compliance.

Our clients include global pharmaceutical, biotechnology, and medical device companies driving the future of healthcare manufacturing and technology.

Job Title: NC/CAPA Governance Moderator & RCPS Lead

Job Description:

This role is responsible for end-to-end NC/CAPA governance execution within GMP-regulated Pharma environments, with strong emphasis on governance moderation, escalation management, KPI visibility, RCA facilitation, and RCPS coaching support. The NC/CAPA Governance Moderator & RCPS Lead drives operational governance discipline supports cross-functional coordination, and strengthens investigation effectiveness across Operations, MSAT, GET, QA, Engineering, and other operational functions.

The role collaborates closely with Quality, Manufacturing, Operational Excellence, Engineering, Compliance, and cross-functional stakeholders to ensure timely NC/CAPA execution, sustainable operational follow-through, improved RCA maturity, and governance visibility. Strong experience in Operational Excellence governance structures and hands-on operational engagement within GMP-regulated environments is required.

Qualification:

• 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
• 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)

Job 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 recurring 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

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 Excellence
• 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.)