Job Description
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. This position is responsible for maintaining quality oversight for Contract Manufacturing Operations (CMO’s) utilized by GE Healthcare Pharmaceutical Diagnostic (PDx) Division. Develop, monitor and maintain positive relationships with GE our External CMO partners encouraging strong collaboration, continuous improvement, transparency and accountability. To ensure manufactured sterile Finished Product meet or exceed GE Healthcare quality, safety and regulatory requirements. Job Description Roles and Responsibilities Complete supplier qualification activities for prospective Contract Manufacturing Operations. Maintain quality oversight for a number of Contract Manufacturing Operations. Act as a single point of contact for all quality related activities at Contract Manufacturer. Manage all critical quality related issues (deviations, complaints, regulatory non-compliances etc). Assure Corrective and Preventive Action plans are developed and executed appropriately. Develop and maintain Quality Agreements between GE Healthcare and Contract Manufacturers. 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. Required Qualifications 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. Several years of professional experience in supplier quality/ quality operations. 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. An ability to travel (up to 30%). Desired Characteristics Pharmaceutical experience. Qualified Person Certification. 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. Experience managing Contract Manufacturing operations (ideally Sterile Fill Finish). Experience perform release activities for Pharmaceutical Products would also be desirable. 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 #J-18808-Ljbffr