Job Description Summary

As a member of the PET QA team, the QA Leader supports the maintenance and improvement of quality standards in the PET Global Supply Chain by working with third party manufacturers to ensure continuous manufacturing capability for GEHC products and then monitoring their performance via reviews and audits. The job holder will also represent QA in supply chain projects.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. 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.

Job Description

Essential Responsibilities

• Managing the quality relationship through set up and continuous oversight of multiple third party manufacturing sites to achieve consistent product quality and compliance to applicable regulatory requirements
• Conducting reviews, performing audits, clearly documenting findings and identifying risk across the PET Global Supply Chain
• Clearly communicating audit results and recommendations
• Providing follow up activities to internal and external audits including: identifying root cause, assessing risk and providing direction on potential resolution.
• Supporting routine internal QA operating mechanisms to ensure compliance and continuous improvement of the supply chain and quality management system
• Supporting activities related to product registrations and regulatory processes
• Representing QA on technology transfer and product / process improvement projects

Qualifications /Requirements

• Bachelors degree in a Scientific, Engineering, Computer Science, core Life Science discipline, or a combination of training and experience demonstrating the equivalent

• 3+ years of Quality Assurance/Regulatory Assurance experience in the pharmaceutical industry;
• Supervisory/management experience

Desired Characteristics

• Certified Auditor or Lead Auditor
• Experience working in remote teams and with people in different countries
• Knowledge and experience of the manufacture of radiopharmaceuticals and /or medical devices
• Experience hosting and /or responding to regulatory GMP or ISO inspections
• Strong track record of identifying and fixing compliance issues
• Strong process improvement mindset, passion for quality

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.

For U.S. based positions only, the pay range for this position is $98,880.00-$148,320.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Application Deadline: December 27, 2024