Job Description Summary
The Senior QA Site Manager is responsible for ensuring PDx regional quality and regulatory compliance of an EMEA region, while driving process effectiveness and efficiency.
The Senior QA Site Manager represents GE Healthcare PDx to external agencies and champions the evolution of the quality culture for the region.
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.
Directing the Site Quality Management System, fully integrated into the GE Global Quality Management System, including cross-functional, 3rd party partners and country-specific processes.
Your role is responsible for regional compliance covering voluntary, regulatory and company quality requirements and will champion quality initiatives at all levels of the organization in the region.
Maintaining and improving all aspects of Quality Planning.
Overseeing all Quality-related communications and training requirements for all employees.
Establishing positive relationships with outside agencies and 3rd party partners such as wholesalers, distributors and GDP suppliers.
Ensuring audit & inspection readiness of all sites in the region.
Overseeing the Deviations / Investigations, Corrective Action / Preventive Action activities and Complaint Handling Programs.
Report on Quality System effectiveness and requirements to management team as required including compliance of 3rd party GDP partners in the region.
Driving the definition of site quality objectives, metrics, reporting and operating mechanisms.
Accountable for each of the metrics for the business (i.e. complaint, internal audit score, employee engagement, etc.) and management review process
Participating in selected global initiatives to share best practices and leverage quality synergies.
Acting as Management Representative for Quality at the Region.
Qualifications and experience
This role requires significant experience in the Quality & Life Sciences Quality. Knowledge level is comparable to a Master's degree from an accredited university or college.
Significant years of professional experience and understanding of product distribution, manufacturing, quality assurance and servicing in the medical equipment and pharmaceutical industry.
Strong Leadership skills and substantial supervisory / management experience, including hiring, training, coaching and performance management activities.
Hands-on experience with Good Distribution practice, EU Directives, FDA, QSR, ISO, MDD and / or other international quality systems requirements.
Proven track record in performing external and internal audits.
Ability to read, analyze, and interpret business plans, technical procedures and governmental regulations.
Effective report, business correspondence and procedure writing skills.
Good problem identification, multivariable analysis and creative resolution aptitude.
Proven process development and project management skills.
Strong interpersonal and leadership skills
Strong computer skills.
Strong oral and written communication skills in English
A valid work permit.
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.
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.
Relocation Assistance Provided : No