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General Electric QA Leader - PDx Molecular Imaging in Arlington Heights, Illinois

We are the doers. The leaders. The makers. The change-bringers. We are all different, uniting to solve the world’s toughest challenges. Our teams are hungry to make history, acting with integrity to relentlessly improve people’s lives. With every weld, every sale, and every code we write we keep the world in motion. It’s time to stop dreaming about the future; let’s build it together.

This position is responsible for the oversight of the GEHC 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.

Job Description

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 guidelinesMaintains 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

Quality Specific Goals: Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position Complete all planned Quality & Compliance training within the defined deadlines Identify and report any quality or compliance concerns and take immediate corrective action as required Meet GE Healthcare QMS procedure deployment plan datesAssure PET CMO manufacturing facilities are properly prepared for external compliance inspections with no systemic or warning letter findings against GE Healthcare outsourced activities. Assure specific quality goals are established and met for compliance, training, CAPA, complaints and production process controls.

Qualifications/Requirements :

Minimum of a Bachelor’s degree (or high school diploma/GED plus 4 years working experience) Demonstrated understanding of product development, manufacturing, quality control and servicing in a pharmaceutical environmentMinimum 1 year Quality Assurance/Regulatory Assurance experience in the pharmaceutical industry Prior experience using word processing, spreadsheet, and presentation softwareDemonstrated experience with regulations in the pharmaceutical industries

Desired Characteristics :

5 years Quality Assurance/Regulatory Assurance experience in the pharmaceutical industry 5 years’ experience in PET or nuclear medicine radiopharmaceutical experience in either production or quality assurance roles. 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 collaboration, negotiation & conflict resolution skills Excellent oral communication & report, business correspondence & procedure-writing skillsProven mentoring and coaching abilities, demonstrated ability to motivate & inspire others Proven leadership skills (experience successfully managing people/projects/issues)Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure complianceChange agent with energy, passion & enthusiasm to drive change Demonstrated effective interpersonal, teamwork & networking skillsExceptional analytical, problem solving & root-cause analysis skillsAbility to make decisions, even when under pressure & take ownership for assigned projects and programs Ability to multi-task & handle tasks with competing priorities effectively Integrity: Accepting & adhering to high ethical, moral & personal values in decisions, communications, actions & when dealing with othersExternal Focus: Understanding customer needs, marketplace dynamics, industry trends, & the competitive landscape in the industry/function & considering the external impact of business activities & decisions on the external environment Inclusiveness: Energizing others by building a connection with the team through personal involvement & trust & providing feedback & coaching to help develop others Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed & accuracy based on best available information & communicating priorities clearly & concisely

Additional Eligibility Qualifications :

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).

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at . at 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).

Relocation Assistance Provided: No