Quality System Specialist

Location: Hoofddorp

Contract Duration: 6 Months (No Possibility of Extension)

Start Date: ASAP

Salary: €89,820 per annum (pro-rated for contract duration)

Are you an experienced Quality Assurance professional with a strong background in GMP-regulated pharmaceutical manufacturing? We are currently seeking a Senior Specialist Quality Systems to join a leading biopharmaceutical manufacturing organization on an urgent 6-month contract basis.

This is an excellent opportunity for someone who thrives in a fast-paced quality environment and enjoys driving compliance, continuous improvement, and cross-functional collaboration within highly regulated pharmaceutical operations.

The Role

You will play a key role in maintaining and improving the site's Quality Management System (QMS). Acting as a quality compliance partner across multiple departments, you will support the management, governance, and continuous improvement of core quality systems, including Change Control, Deviations, CAPA, and Material Review processes.

You will work closely with internal stakeholders across Quality, Manufacturing, Supply Chain, Engineering, and Regulatory functions to ensure compliance with GMP requirements and corporate quality standards.

Key Responsibilities

• Manage and maintain site Quality Systems, ensuring ongoing compliance with GMP requirements and internal quality policies.
• Lead and support Change Control, Deviation, CAPA, and Material Review Board (MRB) processes.
• Deliver training and guidance on Quality Systems procedures and best practices.
• Chair or support multidisciplinary quality review boards and governance meetings.
• Review and approve quality records, including deviations, CAPAs, quality system changes, and associated documentation.
• Support regulatory inspections, internal audits, and quality compliance initiatives.
• Monitor quality metrics and generate management reports to support continuous improvement activities.
• Identify quality risks and implement effective corrective and preventive actions.
• Support cross-functional projects and business initiatives related to quality compliance and operational excellence.
• Contribute to ongoing improvements of quality processes, reporting tools, and automated workflows.
• Provide guidance and day-to-day support to other team members when required.
• Act as deputy for Quality Systems leadership when needed.

Requirements

• Bachelor's degree in Chemistry, Microbiology, Engineering, Life Sciences, or a related technical discipline.
• Minimum 5 years of Quality Assurance experience within a GMP-regulated pharmaceutical or biotechnology environment.
• Strong knowledge of Quality Systems, including:
• Change Control
• Deviations
• CAPA Management
• Material Review Boards (MRB)
• Internal Audits
• ICH Q10 Quality Systems
• Good understanding of EU GMP regulations and pharmaceutical quality requirements.
• Experience supporting audits and regulatory inspections.
• Knowledge of aseptic manufacturing processes is highly desirable.
• Strong experience with quality management systems and electronic quality platforms.
• Proficiency in Microsoft Office applications, including Excel and PowerPoint.
• Experience with reporting and data visualization tools such as Power BI, Smartsheet, or Power Automate is advantageous.
• ATMP, cell therapy, or advanced biologics experience is highly desirable.

Personal Profile

• Excellent written and verbal communication skills.
• Strong stakeholder management and influencing abilities.
• Able to work independently while successfully collaborating across multiple departments.
• Flexible, pragmatic, and solution-oriented approach.
• Comfortable operating in a dynamic and rapidly evolving environment.
• Strong attention to detail with a continuous improvement mindset.

Important Information

• Contract Length: 6 months
• Extension: No possibility of extension
• Start Date: Immediate availability is strongly preferred
• Salary: €89,820 annual salary (pro-rated for contract duration)
• Candidates who can start on short notice or are immediately available will be prioritised.

Candidates must already be locally in the area and visa sponsorship is not possible so anyone that does not meet these requirements cannot be considered.