Qualifications/Requirements: 1. Bachelor's degree and at least 12 years Quality Assurance and/or Quality Systems experience in the pharmaceutical industry (preferred) with some exposure to medical devices and IVD regulations
2. At least 8 years of experience managing/supervising others
3. Demonstrated superior knowledge and expertise in the design, creation, and maintenance of Quality System Manual with emphasis in Pharmaceutical/Drugs regulations USA and worldwide
4. Exposure to medical devices Quality Systems including ISO 13485:2003
5. Significant expertise dealing with regulators and government agencies in market corrections and removals
6. Exposure to FDA-Field Alerts, BPDR, and 806
7. Demonstrated skills and abilities to successfully interact with Regulatory Authorities and in managing Regulatory Authority audits and inspections
8. Proven ability to work effectively with cross-functional stakeholders in a complex, changing, and global environment
9. Willingness to travel globally 25-30% of the time including potential extended period of times assisting sites in preparation and remedial activities
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: 1. Advance Life Sciences Degree
2. Experience interfacing with FDA and global regulatory agencies and ability to interface with central governmental regulators
3. Strong business acumen; uses financial analysis to make important business decisions and understand key financial metrics, can articulate the company?s business vision and key business objectives, understands business trends and cycles
4. Experience in multi-QMS (Pharma/Drugs, Medical Devices, IVD, and CLIA) management systesm
5. Able to respond/react with appropriate urgency/professionalism and make decisions under pressure/stress
6. Ability to comprehend and communicate/translate key regulatory body requirements/expectations and ability to read, analyze and interpret scientific and technical journals, financial reports and legal documents.
7. Ability to respond to escalated inquiries/complaints form customers/regulatory bodies and members of the business community
8. Ability to detect trends/shifts in requirements and align/shift internal organization priorities and actions accordingly
9. Prior experience creating process workflows for data collection.
10. Demonstrated ability to lead teams across regions/cultures/sites.
11. Thorough understanding of Operations and Quality, particularly how a manufacturing site and/or regions, sales, and service sites function.
12. Ability to help design and implement IT solutions related to compliance and process improvement.