General Electric QA Leader - PDx Molecular Imaging in Arlington Heights, Illinois
Job Description Summary
This position is responsible for the oversight of the GE Healthcare Pharmaceutical Diagnostics (PDx) Molecular Imaging external PET CMO radiopharmaceutical manufacturing facilities. Individual will perform continual review and assessment of metrics, reporting and operating data for the oversight of external PET CMO manufacturing facilities.
Individual will also perform routine audits of PET CMO manufacturing sites to ensure compliance to GMP, IND/NDA and quality assurance agreements.
Essential Responsibilities :
Accountable for ensuring full quality and regulatory compliance of CMO facilities to GE Healthcare and regulatory expectations
Ensures CMO audit readiness and conduct the Quality System audits; prepares and executes Quality Management System reviews Responsible for stopping production, issue product holds (stop orders), release products and sign off on project milestones (i.e. New Product Introduction) as required to operate within regulatory guidelines
Maintains positive agency relationships to support effective partnerships; Liaises with regulatory agencies upon CMO inspections and participates in external technical forums
Performs CMO compliance assessment and remediation plans while influencing CMO execution, functional policy, local research and development programs, communications and training requirements for Quality matters when related to GE Healthcare outsourced activities
Assure PET CMO manufacturing facilities are properly prepared for external compliance inspections with no systemic or warning letter findings against GE Healthcare outsourced activities and assure specific quality goals are established and met for compliance, training, CAPA, complaints and production process controls.
Bachelor’s degree or higher in a related field (or high school diploma/GED and at least 4 years working experience)
Demonstrated understanding of product development, manufacturing, quality control and servicing in a pharmaceutical environment
Minimum of at least 1 year Quality Assurance/Regulatory Assurance experience in the pharmaceutical industry
Demonstrated experience with regulations in the pharmaceutical industries
Desired Characteristics :
5 years Quality Assurance/Regulatory Assurance experience in the pharmaceutical industry with at least 5 years’ experience in PET or nuclear medicine
Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
Ability to make decisions, even when under pressure & take ownership for assigned projects and programs
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.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer (https://assets.phenompeople.com/CareerConnectResources/GE11GLOBAL/en_global/desktop/assets/images/poster_screen_reader_optimized_w_supplement.pdf) . 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.
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
As a federal government contractor, GE requires U.S. employees to be fully vaccinated against COVID-19 unless you receive an approved medical or religious accommodation. Proof of vaccination will be required.
Relocation Assistance Provided: No