GE HealthCare Quality Compliance Leader 

Netherlands, North Brabant, Eindhoven 

264838254

Essential responsibilities

• Key member of the Quality Leadership Team contributing to the overall success and direction of the Eindhoven site.
• Ensure full quality and regulatory compliance of the facility, while driving process effectiveness and efficiency at the site.
• Proactively identify and address potential quality and compliance issues, working collaboratively with cross functional teams to implement preventive measures.
• Collaborate and lead/integrate quality activities and considerations for site expansion and change activities
• Work with Manufacturing, Engineering, Validation and NPI teams to drive changes that will reduce quality issues and result in higher long-term reliability.
• Lead and coordinate change projects from Global Quality at the Eindhoven site to ensure future readiness
• Proactively leading and supporting (site) projects and process improvement initiatives from a Quality perspective.
• Lead and support critical investigations and problem-solving on site as needed.
• Utilize data driven insights to identify trends, root causes and areas for improvement.
• Drive risk reduction proactively leveraging the site risk register
• Benchmark other sites and industry standards to drive best in class practices
• Ensure the site and business are fully prepared for external and internal compliance inspections, aiming for non-systemic results and no critical findings. Collaborate closely with business partners to maintain audit readiness at all times.
• Have external focus to understand business and Quality trends in the global supply chain and implement best practices in Eindhoven site.
• Identify skills and competency gaps in the quality teams, providing leadership and direction within own functional remit.
• Improve and promote a strong Quality Culture across the site.
• Complying with Environment, Health & Safety (EHS) Policies and applicable laws and regulations.

Basic qualifications and requirements

• Relevant academic degree or academic level obtained by working experience in Life Sciences.
• Minimum of 5 years demonstrated knowledge and experience in pharmaceutical industry regulations, including GMP Eudralex Annex 1 and data integrity guidelines, Quality Management System tools, equipment qualifications and continuous improvement methodologies.
• Experience in conducting audits to verify adherence to cGMP guidelines.
• Experience in leading, coaching and developing employees.
• You have proven Quality Operations experience of managing teams in a fast-paced and complex environment using LEAN mindset, principles, preferably in a pharmaceutical environment.
• Proven track record of driving projects forward and delivering results without supervision.
• Strong communication and collaboration skills to work effectively with cross-functional teams and regulatory bodies.
• You are a confident decision maker and effective communicator with strong leadership skills.
• Actively engaged and proactive in driving initiatives and change.
• Clear thinker who can analyze data to establish a direction to proceed.
• Excellent problem-solving skills and the ability to lead investigations.
• Ability to adapt to constant change and influence positive change effectively.
• Strong organizational skills.
• Excellent verbal and written communication skills in Dutch and English.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support