Quality Lead Specialist

Chalfont St Giles, England, United Kingdom

11/26/2024

Job Description Summary

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.

As a member of the PET QA team, the QA Manager 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. The location of this role is flexible across European sites and not limited to the listed countries

Job Description

Essential Responsibilities

• Managing the quality relationship through set up and continuous oversight of multiple third party
  
  

manufacturing sites in Europe 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

• Bachelor’s Degree or extensive experience in the pharmaceutical or medical device industry or
  
  

equivalent knowledge and experience

• Experience with internal or external quality system audits
• Knowledge and understanding of GMP and /or ISO 13485 requirements for the manufacture of sterile drug products and medical devices
• Demonstrated knowledge of Quality Management System tools
• Proven analytical, problem solving and root cause analysis skills
  
  

Demonstrated project management skills; ability to prioritize, plan, evaluate & execute deliverables for established tactical goals with minimal management oversight

• Demonstrated ability to work in cross-functional teams
• Ability to influence and make recommendations at multiple levels of the company and also with external customers
• Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer’s requirements
• Demonstrated computer skills
  
  

Desired Characteristics

• Certified auditor or lead auditor
• Experience of working in remote teams and with people in different countries
• Knowledge and experience of the manufacture of radiopharmaceuticals and /or medical devices
• Experience of 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
  
  

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.

Behaviors

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