Senior Quality Systems Specialist - GMP, CAPA & Compliance

i‑Pharm Consulting; Hoofddorp; On-site; EUR 70,000 - 100,000; Full time

Job summary

i-Pharm Consulting seeks a Senior Specialist I, Quality Systems to strengthen site-wide Quality Systems in a GMP environment. You will lead change control, deviations, CAPA, and MRB, while supporting regulatory inspections and ongoing compliance.

The role requires 5+ years of QA experience in pharma manufacturing, strong communication, and the ability to train teams across Quality, Manufacturing, and Technical Operations. Collaboration across sites and continuous improvement initiatives are key.

Qualifications

• Bachelor’s degree in a scientific discipline (Chemistry, Microbiology, Engineering)
• Minimum 5 years of QA in a GMP environment
• Experience with Change Control, Deviations & CAPA, Internal Audits
• Knowledge of ICH Q10, EU GMP Regulations, aseptic manufacturing
• Experience with Quality Management Systems and MS tools (Excel, Power BI, Power Automate, Smartsheet)

Responsibilities

• Manage and maintain Quality Systems including Change Control, Deviations, CAPA, and MRB
• Deliver Quality Systems training and provide compliance support
• Chair or deputy chair for Quality Review Boards and cross-functional committees
• Support regulatory inspections, audits, and quality activities
• Review deviations, CAPAs, quality records, and procedural changes
• Monitor QA metrics and drive continuous improvement
• Maintain GMP documentation and QMS compliance
• Collaborate with Quality, Manufacturing, and Technical Operations
• Support cross-site process improvement initiatives

Skills

Stakeholder management

Strong communication

Independent work

Education

Bachelor's degree in Chemistry, Microbiology, Engineering, or related

Tools

Quality Management Systems

Excel

Power BI

Power Automate

Smartsheet

Job description

i-Pharm Consulting seeks a Senior Specialist I, Quality Systems to strengthen site-wide Quality Systems in a GMP environment. You will lead change control, deviations, CAPA, and MRB, while supporting regulatory inspections and ongoing compliance.

The role requires 5+ years of QA experience in pharma manufacturing, strong communication, and the ability to train teams across Quality, Manufacturing, and Technical Operations. Collaboration across sites and continuous improvement initiatives are key.