Senior Quality Governance Lead — GMP & RCA Leader (6-Month)

Johnson & Johnson; Leiden; On-site; EUR 83,000 - 124,000; Full time

Job summary

A leading healthcare company in Leiden is seeking a Senior Quality Governance Lead to oversee quality processes in its Biotherapeutics Operations division. Responsibilities include setting standards for quality investigations, mentoring staff, and ensuring compliance with regulatory requirements. Candidates should have extensive experience in a GMP-regulated environment and a strong command of quality systems. This 6-month contract position offers a competitive hourly rate.

Qualifications

• Extensive experience in leading and reviewing complex quality investigations within a GMP‑regulated environment.
• Deep expertise in advanced RCA methodologies for identifying systemic failures.
• Strong command of Quality Management Systems and regulatory requirements.
• Proven track record of preparing for regulatory inspections.
• Ability to coach Quality Engineers and Operations staff.

Responsibilities

• Define and enforce standards for quality investigations.
• Mentor Quality Engineers and influence investigation quality.
• Elevate the quality of documentation for audits.
• Lead initiatives to streamline investigation workflows.
• Implement governance for prioritizing investigations based on compliance risk.
• Collaborate with site leadership and business unit directors.

Skills

Expert Investigative Skills

Master of Root Cause Analysis

QMS Subject Matter Expert

Inspection Readiness

Technical Mentorship

Cross‑Functional Influence

Senior Presence

Process Optimization

Risk‑Based Prioritization

Strategic Collaboration

Job description

A leading healthcare company in Leiden is seeking a Senior Quality Governance Lead to oversee quality processes in its Biotherapeutics Operations division. Responsibilities include setting standards for quality investigations, mentoring staff, and ensuring compliance with regulatory requirements. Candidates should have extensive experience in a GMP-regulated environment and a strong command of quality systems. This 6-month contract position offers a competitive hourly rate.