Lead Quality Assurance Specialist - New Product Implementation

Roles and Responsibilities

• Provide QA oversight for new product introduction (NPI) activities, ensuring compliance with GMP and regulatory requirements.

• Lead QA support for technology transfer to CMOs, including review and approval of protocols and risk assessments.

• Ensure external manufacturing sites are inspection-ready and compliant.

• Act as QA lead for external manufacturing partners, ensuring adherence to quality standards and agreements.

• Review and approve GMP documentation including batch records, deviations, CAPAs, and validation reports.

• Monitor CMO performance through quality metrics, audits, and governance processes.

• Provide QA oversight for manufacture of investigational medicinal products (IMPs) supporting clinical trials.

• Support supply of products to pharmaceutical partners for clinical studies.

• Act as QA interface during client audits and health authority inspections.

• Partner with global cross-functional teams to deliver NPI programs.

• Contribute to project governance, risk management, and decision-making.

• Review documentation ensuring it is clear,accurate, andinspection-ready.

• Apply Quality Risk Management (QRM) principles to mitigate risks.

• Support deviation management and CAPA implementation.

• Drive continuous improvement of NPI and external manufacturing quality processes.

• Conduct on-site visits to CMOs to support technology transfer and QA oversight.

• Batch review and release responsibility

• Review of regulatory updates and corresponding maintenance and update of the QMS

Required Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related discipline

• Experience in Quality Assurance within a GMP-regulated environment

• Experience in NPI, technology transfer, validation, or external manufacturing

• Experience working with Contract Manufacturing Organizations (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 and influencing skills

• Solid understanding of GMP and quality systems

• Strong problem-solving and risk-based decision-making skills

• Excellent written and verbal communication skills

• High attention to detail and strong compliance mindset

Additional Information

This role requires travel (approximately 10–25%) to support external manufacturing activities, audits, and technology transfer.

Inclusion and 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 expression, age, disability, protected veteran status or other characteristics protected by law.

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.

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.