QA Operations Lead

Job title:

QA Operations Lead

Company:

GE HealthCare

Job description

Job Description Summary As QA Operations Lead you will lead a group of Qualified Persons (QPs) and oversee the day-to-day operations of our Quality Assurance department. This role is critical in ensuring the highest standards of quality and compliance in our products and processes. You will report to the QA Manager. Fluent Dutch is required and your work location will be in Eindhoven.Job DescriptionGE 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 Qualified Persons, providing guidance, support, and development opportunities.
• Oversee and plan day-to-day QA operations, ensuring compliance with regulatory requirements and company standards.
• Act as the first point of contact for operational and QA-related inquiries and issues.
• Make informed decisions regarding quality matters, ensuring timely and effective resolution.
• Coordinate and manage batch release processes (final product and raw materials), ensuring all products meet quality standards before release.
• Oversee and handle customer complaints efficiently, ensuring thorough investigation and resolution.
• Support writing and reviewing of Product Quality Reviews (PQRs) to ensure comprehensive documentation of product performance.
• Conduct trending analysis to identify and address potential quality issues proactively.
• Connect with Regulatory Affairs (Chemistry, Manufacturing, and Controls (CMC)) to ensure compliance with regulatory standards and support variations in product submissions.
• Develop and implement QA procedures and best practices.
• Collaborate with cross-functional teams to support operational tasks, continuous improvement initiatives and projects.
• Review and approve various documents (e.g., procedures, validation, project) and quality records (e.g., deviations, investigations, change control, CAPA).
• Execute, report and monitor on QA performance metrics, identifying areas for improvement.
• Comply with Environment, Health & Safety (EHS) Policies and applicable laws and regulations.

Basic Requirements and Qualifications

• Academic degree or academic level in a relevant field (e.g. Life Sciences, Pharmacy, Chemistry);
• QP qualification;
• Minimum of 5 years demonstrated strong knowledge and experience in GMP and Quality Assurance within the pharmaceutical industry, preferably in sterile manufacturing;
• 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.

BehaviorsWe 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 RewardsOur 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 supportInclusion & DiversityGE 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.#LI-WRO#OnsiteAdditional InformationRelocation Assistance Provided: No

Expected salary

Location

Eindhoven, Noord-Brabant

Job date

Fri, 18 Apr 2025 03:41:31 GMT

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