At a Glance
- Tasks: Lead quality assurance for innovative diagnostic products and ensure compliance with global standards.
- Company: Join GE HealthCare, a leader in medical technology and innovation.
- Benefits: Competitive salary, travel opportunities, and a commitment to diversity and inclusion.
- Other info: Dynamic role with opportunities for global travel and career growth.
- Why this job: Make a real impact in healthcare by ensuring the quality of life-saving products.
- Qualifications: Bachelor's degree in a relevant scientific field and experience in Quality Assurance.
The predicted salary is between 60000 - 75000 £ per year.
Job Description Summary
As QA Manager – New Product Implementation at GE Health Care, you will provide quality leadership for the development of innovative diagnostic radiopharmaceutical products and associated clinical manufacturing activities.
You will serve as the primary Quality representative for assigned development programs, providing strategic quality guidance throughout product development, technology transfer, and clinical supply activities.
Working closely with R&D, Regulatory Affairs, Technical Operations, Clinical Operations, and external manufacturing partners, you will ensure compliance with global GMP requirements, regulatory expectations, and GE Health Care Quality Management System requirements.
Responsibilities
- Serve as the Quality representative and partner for assigned R&D and clinical development programs.
- Provide QA oversight for product development, technology transfer, and clinical manufacturing activities.
- Lead quality support activities associated with qualification and onboarding of Contract Manufacturing Organizations (CMOs).
- Review and approve GMP and quality documents, including protocols, reports, investigations, deviations, CAPAs, change controls, and quality agreements.
- Support manufacture and release activities for investigational medicinal products (IMPs) used in clinical studies.
- Partner with cross‑functional teams to ensure quality requirements are effectively incorporated throughout the product development lifecycle.
- Facilitate and participate in quality risk assessments.
- Lead or support investigations, root cause analyses, and CAPA activities.
- Support supplier audits, internal audits, client audits, and regulatory inspections.
- Monitor quality metrics and identify opportunities for continuous improvement.
- Participate in governance meetings with CMOs and development partners.
- Provide guidance and coaching to project teams on GMP requirements and quality systems.
- Support continuous improvement of R&D Quality processes and systems.
- Required Qualifications
- Bachelor's degree in Pharmacy, Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, Life Sciences, or a related scientific discipline.
- Strong experience within Quality Assurance in a GMP‑regulated pharmaceutical, biotechnology, or radiopharmaceutical environment.
- Experience supporting product development, technology transfer, clinical manufacturing, validation, or external manufacturing operations.
- Strong knowledge of GMP regulations, ICH guidelines, quality risk management, and pharmaceutical quality systems.
- Experience working with CMOs.
- Demonstrated ability to lead complex quality initiatives in a matrix environment.
- Experience supporting audits, inspections, investigations, CAPAs, and change controls.
- Strong communication, influencing, and stakeholder management skills.
- Preferred Qualifications
- Experience with radiopharmaceuticals, sterile manufacturing, or aseptic processing.
- Lead Auditor qualification or equivalent quality certification.
- Experience supporting global clinical development programs.
- Experience interacting with FDA, EMA, MHRA, or other health authorities.
- Additional Information
This role requires approximately 10–20% global travel to support technology transfer activities, external manufacturing oversight, audits, inspections, and project‑related meetings.
Inclusion and Diversity
GE Health Care 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 expression, age, disability, protected veteran status or other characteristics protected by law.
- Relocation Assistance
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QA Manager - New Product Introduction employer: MS0160 GE Healthcare Limited
At GE HealthCare, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation. As a Lead QA Specialist in New Product Implementation, you will have the opportunity to work with cutting-edge technology in a global environment, ensuring compliance and quality in healthcare solutions. We are committed to your professional growth, providing continuous learning opportunities and a supportive atmosphere where your contributions can make a real impact.
Contact Details:
MS0160 GE Healthcare Limited Recruitment Team
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