GE Healthcare provides transformational medical technologies that are shaping a new age of patient care. GE Healthcare's expertise in medical imaging and information technologies, medical diagnostics, patient monitoring and life support systems, disease research, drug discovery, and biopharmaceutical manufacturing technologies is helping physicians detect disease earlier and to tailor personalized treatments for patients. GE Healthcare offers a broad range of products and services that are improving productivity in healthcare and enhancing patient care by enabling healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries.
Role Summary/Purpose
The Quality Assurance Director - Clinical Business Solutions, as an active member of the management team, is responsible for creating and supporting a Quality culture across sites by driving compliance for the CBS Business. This includes being responsible for the total quality management system for the business and driving Quality metrics across all sites and CBS product lines – Specifically, this position is responsible for 7 product lines and 10 sites.
Essential Responsibilities
· Having the authority to issue concessions, stop production, make decisions about people and budget accountability, and provide input during the Session C process
· Leading and driving specific product compliance across poles/sites--owns the Corrective and Preventive Actions process and training, employee training and development, internal audit programs, and the new product introduction (NPI) milestone approval process
· Accountable for each of the metrics for the business (i.e. complaint investigation, internal audit score, product quality, employee engagement, etc.) and management review process
· Influencing hiring decisions, product compliance process development, and new product introduction (NPI)
· Serving on Global or functional Quality Council(s)
Qualifications/Requirements
1. Bachelor’s degree
2. Significant Multi-Modality Sites: Minimum 10 years Quality Assurance/Regulatory Assurance experience
3. Small and Simple Sites: Minimum 8 years Quality Assurance/Regulatory Assurance experience
4. Minimum 5 years experience in the medical device or pharmaceutical industry
5. Minimum 4 years supervisory/management experience
6. Demonstrated knowledge of Quality Systems (demonstrated experience with ISO, GxP, FDA and other key regulatory bodies) and experience with new product introduction process (NPI)
7. Knowledge of and exposure to manufacturing or engineering processes
8. Ability to communicate using English (or local language)
9. Prior experience using word processing, spreadsheet, and presentation software
Additional Eligibility Qualifications
GE will only employ those who are legally authorized to work. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
Desired Characteristics
1. Demonstrated managerial/leadership experience such as work planning, delegating and evaluating
2. Global regulatory experience & demonstrated experience interfacing with FDA
3. Familiar with classic Quality tools & experienced in applying them to monitor function performance
4. Demonstrated project management skills to plan & deliver on established strategic goals
5. Ability to successfully identify, assess & manage risk proactively & be accountable for actions/tough decisions
6. Visibly demonstrates comfort & efficacy in presenting to and in communicating with others including regulatory agencies & business leaders
7. Strong business acumen-understands key financial metrics, understands business trends & cycles & is able to influence key business strategies & initiatives, demonstrates knowledge of key business measurements (i.e., market, suppliers, competition, performance measures) & is able to link QA strategy to this framework
8. Strong influencing & relationship building, mentoring, coaching & networking skills
9. Business partnership skills: can interface with top organizational leadership & internal & external customers, responding in a professional manner
10. Demonstrated collaboration, negotiation & conflict resolution skills
11. Ability to effectively lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
12. Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures)
13. Integrity: Adhering to high ethical, moral & personal values in decisions, communications & actions
14. Inclusiveness: Building a connection with the team through personal involvement & trust & providing feedback & coaching to help develop others
15. Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed & accuracy based on best available information & communicating priorities clearly
16. Expertise: Has confidence & perspective the comes through depth in industry to impact growth, demonstrating leadership throughout different business cycles & continually striving to increase knowledge
17. Imagination: Taking risks on people & ideas, generating new & unique ideas & acting as an advocate of innovation to accelerate GEHC competitive advantage
18. Prior GEHC experience
