QA Systems and Compliance Lead

Job Description SummaryAs QA Systems and Compliance Lead you will lead a group of QA professionals and oversee the Quality Management System and ensure KPI’s are met. This role is critical in ensuring the highest standards of quality and compliance in our products and processes. This role requires fluent Dutch and your work location will be Eindhoven.

Job Description

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

• Lead, engage and manage a team of QA professionals, providing guidance, support, and development opportunities.
• Oversee and plan day-to-day QA systems activities, ensuring compliance with regulatory requirements and company standards.
• Lead the maintenance of quality management systems, such as document management, handling of deviations, investigations, CAPA and Change Control, training management, auditing, regulatory intelligence and risk management in compliance with GxP.
• Identify and implement opportunities to improve quality systems.
• Oversee supplier management, ensuring effective communication and collaboration with global supplier quality teams.
• Ensure timely completion of quality records (e.g. deviations, investigations, CAPA, Change Control) and actively follow up with team to ensure completion.
• Ensure timely completion of periodic reviews and document updates.
• Review and implement updated (global) procedures.
• Oversee and support the preparation and execution of the Quality Management Review (QMR) process.
• Execute the self-inspection program to ensure continuous compliance and improvement.
• Act as the first point of contact for QA systems related inquiries and issues.
• Develop and implement QA procedures and best practices.
• Collaborate with cross-functional teams to support operational tasks, continuous improvement initiatives and projects.
• Execute, report and monitor on QA performance metrics, identifying areas for improvement.
• Review and approve various documents (e.g., procedures, validation, project) and quality records (e.g., deviations, investigations, change control, CAPA).
• Comply with Environment, Health & Safety (EHS) Policies and applicable laws and regulations.

Basic Requirements and Qualifications

• Minimum bachelor degree in a relevant field (e.g. Life Sciences, Pharmacy, Chemistry);
• Demonstrated strong knowledge and experience in GMP and Quality Assurance within the pharmaceutical industry;
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies and understanding of site level products and related processes;
• Experience in leading, coaching and developing employees.

Desired Characteristics

• Effective interpersonal skills engages effectively with team members and stakeholders, fostering strong working relationships.
• Demonstrates drive and positive energy: ability to lead, develop, inspire and motivate the team.
• Strong organizational skills.
• Ability to adapt to constant change and influence positive change effectively.
• Excellent verbal and written communication skills in Dutch and English.
• Ability to make decisions under pressure, take ownership for actions and lead by example.

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 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

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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