Roles Responsibilities
Provide QA oversight fnew product introduction (NPI) activities, ensuring compliance with GMP regulatory requirements.
Lead QA support ftechnology transfer to CMOs, including review approval of protocols risk assessments.
Ensure external manufacturing sites are inspection-ready compliant.
Act as QA lead fexternal manufacturing partners, ensuring adherence to quality standards agreements.
Review approve GMP documentation including batch records, deviations, CAPAs, validation reports.
MonitCMO performance through quality metrics, audits, governance processes.
Provide QA oversight fmanufacture of investigational medicinal products (IMPs) supporting clinical trials.
Support supply of products to pharmaceutical partners fclinical studies.
Act as QA interface during client audits health authority inspections.
Partner with global cross-functional teams to deliver NPI programs.
Contribute to project governance, risk management, decision-making.
Review documentation ensuring it is clear, accurate, inspection-ready.
Apply Quality Risk Management (QRM) principles to mitigate risks.
Support deviation management CAPA implementation.
Drive continuous improvement of NPI external manufacturing quality processes.
Conduct on-site visits to CMOs to support technology transfer QA oversight.
Batch review release responsibility
Review of regulatory updates corresponding maintenance of the QMS
Required Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, related discipline
Experience in Quality Assurance within a GMP-regulated environment
Experience in NPI, technology transfer, validation, external manufacturing
Experience working with Contract Manufacturingganizations (CMOs)
Knowledge of global regulatory requirements (China, FDA, EMA, ICH)
Desired Characteristics
Radiopharmaceutical industry experience preferred
Ability to work in a global, cross-functional matrix environment
Strong stakeholder management influencing skills
Solid understanding of GMP quality systems
Strong problem-solving risk-based decision-making skills
Excellent written verbal communication skills
High attention to detail strong compliance mindset
Additional Information
This role requires travel (approximately 10–25%) to support external manufacturing activities, audits, technology transfer.
Inclusion Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national ethnicigin, sex, sexualientation, gender identity expression, age, disability, protected veteran status other characteristics protected by law.
We expect all employees to live breathe our behaviors: to act with humility build trust; lead with transparency; deliver with focus, drive ownership – always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost flexibility you need to turn your ideas world-changing realities. Our salary benefits are everything you’d expect from anganization with global strength scale, you’ll be surrounded by career opportunities in a culture that fosters care, collaboration support.
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