GMP Quality Systems Leader — Compliance & Improvement

Sire Search; Hoofddorp; On-site; EUR 70,000 - 110,000; Full time

Job summary

Sire Search seeks a Senior Quality Systems Specialist to govern and improve GMP quality systems at its site in Hoofddorp, Netherlands.

You will work with Quality, Operations and cross-functional teams to ensure compliance, robustness and inspection readiness, driving continuous improvement and supporting audits.

Requirements include 5+ years in QA within GMP, strong EU GMP/ICH Q10 knowledge, and experience with Change Control, Deviations, CAPA and MRB.

Qualifications

• 5+ years of Quality Assurance experience within a GMP environment.
• Strong knowledge of GMP, EU GMP, and ICH Q10 requirements.
• Proven experience with Change Control, Deviations, CAPA, and MRB processes.
• Experience in Drug Substance and/or Drug Product environments.
• Strong communication, stakeholder management, and organizational skills.
• Pragmatic and structured approach to quality and compliance.
• Knowledge of aseptic manufacturing and/or ATMP environments is advantageous.
• ASQ Lean Six Sigma or similar certification is a plus.

Responsibilities

• Manage and support Quality Systems including Change Control, Deviations, CAPA, and MRB.
• Maintain and improve quality procedures and coordinate site training.
• Monitor compliance, quality metrics, and management review inputs.
• Identify and manage quality risks in line with EU GMP, ICH Q10, and internal policies.
• Chair or support multidisciplinary quality boards and committees.
• Support audits and regulatory inspections, including preparation and follow-up.
• Review and approve quality documentation, changes, deviations, and CAPAs.
• Drive continuous improvement of quality processes, reporting, and automation.
• Provide backup support to the Quality Systems Lead/Manager when required.

Skills

Quality Systems

GMP Knowledge

Change Control

Deviations

CAPA

MRB

Stakeholder management

Communication

Aseptic manufacturing

ATMP experience

Education

ASQ Lean Six Sigma certification

Tools

Power BI

Power Automate

Smartsheet

MS Office

Job description

Sire Search seeks a Senior Quality Systems Specialist to govern and improve GMP quality systems at its site in Hoofddorp, Netherlands.

You will work with Quality, Operations and cross-functional teams to ensure compliance, robustness and inspection readiness, driving continuous improvement and supporting audits.

Requirements include 5+ years in QA within GMP, strong EU GMP/ICH Q10 knowledge, and experience with Change Control, Deviations, CAPA and MRB.