Job Description Summary
In this Global Pharmaceutical role, you'll be responsible for maintaining quality oversight for suppliers and service providers utilized by the GE HealthCare Pharmaceutical Diagnostic (PDx) manufacturing sites. Develop, monitor and maintain positive relationships with external partners and sites to encourage strong collaboration, continuous improvement, transparency and accountability. Ensure products meet or exceed GE Healthcare quality, safety and regulatory requirements.Job Description
Responsibilities
Complete supplier qualification activities for both existing and prospective external suppliers.
Act as a single point of contact for all quality related activities at external suppliers.
Manage all critical quality related issues (deviations, complaints, regulatory non-compliances etc)
Assure Corrective and Preventive Action plans are developed and executed appropriately.
Responsible to develop and maintain Quality Agreements between GE Healthcare and external suppliers.
Responsible for the coordination and completion of audits, participating in and/or leading audits.
Ensure Change Controls, initiated by supplier or by GE Healthcare are managed appropriately.
Assist in Health Authority inspection preparations and providing support throughout as required.
Track and trend key quality indicators / metrics to monitor supplier and QMS performance.
Assure suppliers comply with all GE Healthcare QMS, procedures and regulatory requirements.
Develop positive relationships with all internal partners, i.e. Sites, Sourcing, Supply Chain etc
Provide quality support for New Product Introductions and transfers project activities.
Interact with Suppliers, Sites and Sourcing to drive improvements to minimize costs of quality.
All other duties as assigned by manager
Qualifications and Requirements:
Bachelors Degree in Science discipline (or non-technical degree with significant experience in manufacturing, engineering or equivalent knowledge or experience or quality assurance experience, or an Associate’s Degree with major manufacturing, engineering, or quality assurance experience) or equivalent knowledge or experience.
Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally).
Proficiency with Microsoft Excel spreadsheet development and analysis.
Extensive experience conducting supplier audits in a regulated environment.
Deep knowledge of global regulations such as GMP, FDA, ISO 9001, and other relevant standards.
Proven success in negotiating and managing Quality Agreements with external partners.
Strong communication and relationship-building skills to influence and collaborate across global teams.
Desired skills:
Ability to effectively communicate within all levels of the organization
Demonstrated collaboration, negotiation & conflict resolution skills.
Excellent oral communication & report-writing skills in both.
Ability to work within a matrix organisation across different cultures
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.
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Additional Information
Relocation Assistance Provided: No