Senior Specialist I, Quality Systems

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

We are partnering with a leading cell therapy organization seeking a Senior Specialist I, Quality Systems to support and enhance site-wide Quality Systems within a highly regulated GMP environment. This is an excellent opportunity to join a team focused on delivering innovative cancer therapies while driving compliance, quality, and continuous improvement initiatives.

Key Responsibilities

• Manage and maintain Quality Systems including Change Control, Deviations, CAPA, and Material Review Board (MRB) processes.
• Deliver Quality Systems training and provide ongoing compliance support across the site.
• Act as chair or deputy chair for Quality Review Boards and cross-functional committees.
• Support regulatory inspections, audits, and quality compliance activities.
• Review and approve deviations, CAPAs, quality records, and procedural changes.
• Monitor, analyse, and report Quality System metrics to support continuous improvement.
• Maintain GMP documentation and Quality Management System compliance.
• Collaborate with internal stakeholders across Quality, Manufacturing, and Technical Operations teams.
• Support cross-site initiatives and process improvement projects.

Requirements

• Bachelor's Degree in Chemistry, Microbiology, Engineering, or a related scientific discipline.
• Minimum 5 years of Quality Assurance experience within a GMP-regulated pharmaceutical, biotech, or manufacturing environment.
• Strong experience with:
• Change Control
• Deviations & CAPA Management
• Internal Audits
• ICH Q10 Quality Systems
• EU GMP Regulations
• Strong understanding of aseptic manufacturing processes.
• Experience using Quality Management Systems and Microsoft tools including Excel, Power BI, Power Automate, and Smartsheet.

Preferred Experience

• ATMP, Cell & Gene Therapy, or Biologics experience.
• ASQ, Lean Six Sigma Green Belt, or Black Belt certification.

Personal Attributes

• Strong communication and stakeholder management skills.
• Flexible, pragmatic, and collaborative approach.
• Ability to work independently within a fast-paced GMP environment.
• Passion for quality, compliance, and continuous improvement.