Posted Position Title Executive - Quality Assurance, Contrast Media

Job Number	1863160
Business	GE Healthcare
Business Segment	Healthcare Quality
Career Level	Experienced
Function	Quality
Function Segment	Quality Assurance
Location(s) Where Opening Is Available	IrelandUnited States
U.S. State, China or Canada Provinces	New Jersey
City	Cork, Ireland or Princeton, NJ
Relocation Expenses	No
Role Summary/Purpose	GE is an equal opportunity employer, offering a great work environment, challenging career opportunities, professional training and competitive compensation. The Contrast Media Executive Leader - Quality owns the compliance activities around the Contrast Media P&L (~1B), drives metrics for all sites in P&L, owns the P&L QMS review and manages the P&L QA team. The Executive Leader - Quality is also responsible for making QA decisions for the P&L on behalf of GEHC.
Essential Responsibilities	• Assuring P&L audit readiness and product compliance with regulations • Shaping the GEHC vision and translates vision into goals, objectives and strategies for the P&L • Quality responsibilities for all US regulated products. Serves a conduit of regulatory/compliance communication with US-FDA. Acts as Quality Leader for the MDx-US headquarters • Making decisions about the P&L budget and head count, drives the strategy for the P&L • Influencing the staffing, training, development and performance management of the QA Leadership Team in a coaching role • Responsible for monitoring and driving all quality metrics in the P&L, across cultures and sites Quality Specific Goals: 1. 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 2. Complete all planned Quality & Compliance training within the defined deadlines 3. Identify and report any quality or compliance concerns and take immediate corrective action as required 4. Promulgate GxP within the respective P&L 5. Meet GE Healthcare QMS procedure deployment plan dates for each site 6. Assure GE Healthcare is properly prepared for external and internal compliance inspections by having results from their inspections be non-systemic and without warning letters 7. Assure specific site and business goals are established and met for compliance, training, CAPA, complaints and production process controls. 8. Operates a local inspection program and manages follow-up activities to manage Non Conformances
Qualifications/Requirements	• Bachelor’s degree (or high school diploma/GED plus 4 years working experience and understanding of Quality or Regulatory Assurance) • Minimum 10 years experience with increasing responsibility in Quality Assurance/Regulatory Affairs • Including at least 7 years experience in the pharmaceutical industry • Including at least 5 years experience managing/supervising professionals • Demonstrated knowledge of Quality Systems (demonstrated experience with ISO, GxP, FDA and other key regulatory bodies) and experience with new product introduction process (NPI) • Knowledge of and exposure to manufacturing or engineering processes • Ability to communicate using English (or local language) • Prior experience using word processing, spreadsheet, and presentation software • Location in either Cork, Ireland or Princeton, NJ
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 background investigation and drug screen.
Desired Characteristics	• Experience in QA in Pharmaceutical industry • Demonstrated experience with applying classic Quality tools Experience interfacing with FDA & global regulatory agencies & ability to interface with central governmental regulators • Strong business acumen-uses financial analysis to make important business decisions & understands key financial metrics, can articulate the company’s business vision & key business objectives, understands business trends & cycles • Able to respond/react with appropriate urgency/professionalism & make decisions under pressure/stress • Ability to comprehend & communicate/translate key regulatory body requirements/expectations & ability to read, analyze & interpret scientific & technical journals, financial reports & legal documents • Ability to respond to escalated inquiries/complaints from customers, regulatory bodies & members of the business community • Demonstrated ability to lead teams across poles/cultures/sites • Ability to detect trends/shifts in requirements & align/shift internal organization priorities & actions accordingly (getting ahead of the curve) • Influencing/advocacy-able to determine a position & argue it effectively within the business context • Integrity: Accepting & adhering to high ethical, moral & personal values in decisions, communications, actions & when dealing with others • External Focus: Understanding customer needs, marketplace dynamics, industry trends & the competitive landscape in the industry & considers the external impact of business activities & decisions on the external environment • Inclusiveness: 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 • Expertise: Has confidence & perspective the comes through depth in industry to impact growth, demonstrating leadership throughout different business cycles & continually striving to increase knowledge • Imagination: Taking risks on people & ideas, generating new & unique ideas & acting as an advocate of innovation to accelerate GEHC competitive advantage