Director Global Quality Systems

I have an urgent requirement for for a Director of Global Quality Systems for a Biotechnology company in the Netherlands.

Job Overview:

The Global Quality Systems Director is tasked with envisioning and implementing a cutting-edge quality framework across all entities. The role involves strict adherence to regulatory standards (EMA, FDA, etc.) and the provision of top-tier quality systems for GxP departments.

Job Purpose:

Global Unit Management:

• Ensure the implementation of financial and personnel policies for Quality Systems.
  • Organize activities and workload across all entities, maintaining optimal staffing levels.
  • Foster a motivated workforce with low absenteeism and a vibrant knowledge exchange.

Short-Term Plan Execution:

• Develop and manage departmental budgets across various legal entities.
  • Translate short-term company plans into actionable departmental plans.
  • Guarantee plan implementation within budget, meeting financial, safety, operational, and GMP requirements.

Contribution to Long-Term Plans and Strategy:

• Align department functioning with the organization.
  • Influence unit plans and strategy, contributing to overarching plans.
  • Ensure implementation and support of long-term plans, fostering optimal alignment and cooperation.
  • Initiate innovative organizational development and drive change processes.

Quality System Department Results:

• Coach business owners on compliance processes.
  • Lead and monitor audit plan implementation, identifying control gaps and opportunities.
  • Prepare timely audit reports for executive management and the Board of Directors.
  • Establish efficient and compliant quality governance structures.

Leadership:

• Recruit, lead, coach, and appraise employees.
  • Develop effective departmental structures with a positive culture.
  • Ensure effective career and education paths for department employees.
  • Foster good cooperation between department members across entities.

Stakeholder Management:

• Act as the point of contact for authorities on quality matters.
  • Ensure timely and accurate communication with authorities and third parties on quality matters.

GxP Expertise:

• Possess a broad understanding of regulatory GxP requirements.
  • Make decisions on GxP matters, manage SOPs, deviations, and change control.
  • Follow mandatory GxP training and maintain appropriate training records.

Qualifications:

• Academic master's degree.
• 10 years of relevant GMP quality environment experience.
• Expert knowledge of QMS, GMP legislation, and regulations on a national, FDA, and EU level.
• Strong analytical and problem-solving skills.
• Effective social and leadership skills.
• Excellent oral and written communication skills in English; knowledge of French and/or Dutch is a plus.

If you are interested in applying or this position, click apply and give me a call!

Darwin Recruitment AG is a Zurich based, SECO licensed, privately owned subsidiary of Darwin Professional Staffing Group Ltd (a Global IT Recruitment Consultancy).

Darwin Recruitment AG manages client relationships whilst also utilising Darwin Professional Staffing Group databases and networks to source Candidates and fulfil client requests.

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