Quality Systems Specialist - GMP

Are you an experienced Quality Assurance professional with a strong background in GMP-regulated environments and Quality Systems management? Our client is seeking a Senior Specialist I, Quality Systems to play a pivotal role in maintaining compliance, driving continuous improvement, and supporting quality governance across a highly innovative biopharmaceutical operation focused on advanced therapies. This is an influential senior-level position offering broad exposure to cross-functional stakeholders, leadership responsibilities, and the opportunity to contribute to life-changing treatments. If you are ready for your next challenge, we encourage you to apply.

Job Description
As a Senior Specialist I, Quality Systems, you will serve as a key quality partner responsible for the oversight, implementation, maintenance, and continuous improvement of critical Quality Management System processes. Working within a collaborative Quality Systems team, you will ensure quality processes remain compliant with regulatory requirements and internal standards while supporting operational excellence across the organisation.
The role encompasses ownership and governance of core quality systems, including Change Control, Deviations, CAPA, and Material Review processes. You will collaborate with site and cross-site stakeholders, support regulatory inspections and audits, provide training to end users, and contribute to strategic quality initiatives. In addition, you will analyse quality metrics, identify compliance risks, lead improvement projects, and provide guidance to team members while acting as deputy to the Senior Manager Quality Systems when required.

Responsibilities

• Manage and maintain Quality System processes in accordance with GMP regulations and internal quality standards.
• Oversee Change Control activities and provide associated training and administration.
• Chair or serve as deputy chair for quality review boards and multidisciplinary committees.
• Lead the management of Deviation and CAPA processes, including review and approval of records.
• Coordinate Material Review Board activities and support disposition decision-making.
• Ensure Quality Systems remain compliant with regulatory requirements and quality policies.
• Support internal audits, customer audits, and regulatory inspections.
• Maintain cGMP documentation and ensure controlled documentation processes are followed.
• Review and approve proposed changes to systems, procedures, and quality processes.
• Monitor, analyse, and report quality metrics and management information.
• Identify quality risks and implement corrective and preventive improvement actions.
• Support automated reporting tools, dashboards, and workflow solutions when needed.
• Mentor and support colleagues within the Quality Systems team.
• Contribute to cross-functional business initiatives and continuous improvement programmes.
• Act as deputy for the Senior Manager Quality Systems when required.

Requirements

• Bachelor's degree in Chemistry, Microbiology, Engineering, or a related scientific or technical discipline.
• Minimum of 5 years of Quality Assurance experience within a GMP-regulated pharmaceutical, biotech, drug substance, or drug product environment.
• Strong knowledge of EU GMP regulations, pharmaceutical legislation, and ICH Q10 Quality Systems.
• Proven experience with Change Control, Deviations, CAPA, Material Review Boards, Internal Audits, and related Quality Management Systems.
• Sound understanding of aseptic manufacturing processes.
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
• Experience using Smartsheet, Power BI, Power Automate, and electronic Quality Management Systems.
• ASQ certification, Lean Six Sigma Green Belt or Black Belt are preferred.
• Strong written and verbal communication skills in English.
• Ability to work independently while effectively collaborating with technical and scientific stakeholders.
• Pragmatic, adaptable, and solution-oriented approach in a dynamic environment.
• Proven ability to support teams and drive continuous improvement initiatives.

Benefits

• Region: North Holland
• Contract: 6 month contract trough Oxford Global Resources
• Working hours: Monday to Friday, 09:00 to 17:00, hybrid working possible
• Salary range: €6900,-
• Vacaturenummer: 27635