In this position you take ownership of core Quality Systems during the construction and commissioning phase of a new state-of-the-art facility. You’ll combine hands-on execution with strategic oversight and design, making sure the site reaches cGMP readiness and stays inspection-ready throughout. You will be closely involved in shaping system design, embedding global guidelines, and safeguarding compliance during a critical phase of organisational growth for this new facility.Key elements of your role include:

• Leading the establishment and continuous improvement of key Quality Systems;
• Translating global and regulatory requirements into practical site-level procedures;
• Driving cGMP readiness across commissioning, qualification and start-up activities;
• Overseeing Change Control, Deviation, Investigation & CAPA performance;
• Acting as system SME for internal and external audits and regulatory inspections;
• Coordinating quality deliverables across major CAPEX projects;
• Managing documentation such as Site Master File, Validation Master Plan and Compliance Plans;
• Coaching colleagues and championing a strong Quality & Compliance culture. 

You operate with a structured, risk-aware mindset and feel comfortable in both project and operational settings. You know how to build systems from the ground up, engage stakeholders, challenge assumptions, and drive quality outcomes at pace. To be successful, you bring:

• A relevant scientific degree (e.g. Pharmacy, Biology, Chemistry, Process Technology);
• Strong experience in pharmaceutical Quality Systems and regulatory expectations (EU/FDA);
• Proven capability to support or defend systems during audits and inspections;
• Ability to translate GMP theory into practical tools and processes;
• Strong systems thinking, attention to detail and natural ownership;
• Experience with contamination control strategies and cleanroom-related requirements;
• Confidence to collaborate across functions and influence in a project environment;
• Fluency in English (preferably also Dutch); willingness to be onsite several days per week. 

You will step into a highly visible, impactful role at the foundation of a new facility. It’s a rare opportunity to shape the QMS landscape of an entire site, work cross-functionally, and influence both strategy and execution. The environment rewards initiative, accountability and collaboration, supported by strong development opportunities. Moreover, you can expect:

• A role with genuine autonomy, ownership and influence;
• Competitive salary and performance-based incentives;
• Comprehensive benefits package including pension and healthcare;
• Ample training and development possibilities for long-term growth;
• A collaborative culture with a strong focus on quality, safety and continuous improvement;
• The chance to contribute directly to a flagship pharmaceutical investment project;
• Daily exposure to complex challenges and cross-functional teamwork;
• A long-term career pathway in an international environment.