Quality and Compliance Leader

Job Description

Summary

As Quality and Compliance Leader, you will play a crucial role in driving continuous improvement, fostering a culture of quality excellence and collaborating cross functionally to enhance overall organizational performance. Reporting to the Site Quality Director, and a member of the Quality (QA/QC) Leadership team for the site, you will be responsible for identifying areas for improvement and leading initiatives to enhance product and service quality and compliance. The ideal candidate will possess strong leadership skills, a proactive mindset and a passion for continuous improvement. The role requires fluent Dutch and your work location will be Eindhoven.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

GE HealthCare Pharmaceutical Diagnostics (PDx) is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world.

GE HealthCare in Eindhoven produces and distributes pharmaceutical products for hospitals worldwide. As part of the Pharmaceutical Diagnostics (PDx) business of GE HealthCare, we support the PDx vision of being the best-in-class supply chain delivering the right dose to the right patient at the right time.

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 the 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.

Behaviors

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership always with unyielding integrity.

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 youd expect from an organization with global strength and scale, and youll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Inclusion & Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or age, disability, protected veteran status or other characteristics protected by law.

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Additional Information

• Relocation Assistance Provided: No
• Locations - Location: Eindhoven, North Brabant, Netherlands, 5612 AP

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