Senior Quality Systems Specialist

Sire Search; Hoofddorp; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality Systems

GMP Knowledge

Change Control

Deviations

CAPA

MRB

Stakeholder management

Communication

Aseptic manufacturing

ATMP experience

Ausbildung

ASQ Lean Six Sigma certification

Tools

Power BI

Power Automate

Smartsheet

MS Office

Jobbeschreibung

The Company

Our client is a global leader in advanced cell therapy, specializing in developing and delivering cutting-edge treatments for patients with serious illnesses. The organization operates state-of-the-art manufacturing facilities and follows the highest GMP standards to ensure quality and safety.

Role Description

As a Senior Quality Systems Specialist, you are responsible for governing and improving key GMP Quality Systems, ensuring processes remain compliant, robust, and inspection-ready. You will work closely with Quality, Operations, and cross-functional stakeholders at site and cross-site level.

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.

Requirements

• 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 an advantage.
• ASQ, Lean Six Sigma, or similar certification is a plus.
• Familiarity with Power BI, Power Automate, Smartsheet, and MS Office is desirable.