Senior Quality Engineer (NC/CAPA Governance)

About the role

NovintiX is seeking a Senior Quality Engineer to lead NC/CAPA governance within GMP‑regulated pharmaceutical environments. The role focuses on moderation of governance meetings, escalation management, KPI visibility, and coaching of RCPS methodologies to improve investigation effectiveness across multiple functions.

Key responsibilities

• Moderate daily NC/CAPA governance meetings and drive structured discussions.
• Coordinate cross‑functional stakeholders from Operations, MSAT, QA, Engineering, GET and support functions.
• Challenge teams on governance processes, timelines, and escalation discipline.
• Ensure action tracking, escalation follow‑up and operational accountability.
• Monitor stakeholder participation and adherence to governance meetings.
• Trend and analyse NC/CAPA activity, recurrence patterns, aging metrics and escalation risks.
• Facilitate Root Cause Analysis (RCA) discussions and RCPS workshops for complex investigations.

Required profile

• Bachelor’s degree in Engineering, Life Sciences or related technical discipline.
• 8–10 years 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 forums.
• Experience in RCA facilitation and RCPS coaching methodologies.
• Lean Green Belt or Black Belt; RCPS certification preferred.
• Strong understanding of GMP, quality systems and the NC/CAPA lifecycle.
• Excellent communication, stakeholder coordination and escalation management skills.
• Dutch language proficiency (mandatory).

Required skills

• NC/CAPA governance
• Root Cause Analysis (RCA)
• RCPS coaching
• Lean Green Belt / Black Belt
• GMP knowledge
• Quality systems management
• Dutch language proficiency