QA Manager - New Product Introduction

Job Description Summary

As QA Manager – New Product Implementation at GE HealthCare, 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 HealthCare Quality Management System requirements.

Job Description

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:

Behaviours:

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.

Additional Information

Relocation Assistance Provided: No