Device Quality Senior Manager
About The Position
The Device Quality Senior Manager supports quality-system integration for AbbVie’s medical-device and combination-product business. The role helps set strategic direction to meet business objectives and sustain these products, while developing, implementing, and maintaining quality-assurance activities that comply with global device and combination-product regulations. The position develops quality-assurance policies and procedures, oversees interrelated medical-device management activities across functions, coordinates quality-system elements and training, and provides tactical support across functions, plants, and affiliates. It implements the medical-device quality system in compliance with corporate, division, and site policies and supports product introductions and design changes. The role also oversees training for revised quality-system policies and procedures, represents AbbVie in external industry groups when appropriate, and works with the Medical Device Centre, Regulatory Affairs, R&D, and Operations Quality Management to consolidate quality oversight. It works with the director and department to achieve related goals and strategic initiatives.
Requirements
- Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or another technical or scientific area.
- At least 8 years of experience with quality assurance and/or quality-system oversight.
- Leadership experience with technical professionals and cross-functional teams, with a results-oriented approach.
- Skill in strategy development, project initiation, selection, coordination, and management, and the ability to solve unique problems.
- Knowledge of regulations and standards affecting devices, biologics, and pharmaceutical products, including ISO standards, the US Code of Federal Regulations, and EU regulations.
- Understanding of how changes in a specific area affect other quality systems and division requirements, with the ability to adjust accordingly.
- Conflict-resolution skills, including persuasive management techniques.
- Strong oral and written communication skills.
Nice To Haves
- Medical-device regulation experience.
- Previous experience interfacing with regulatory agencies.
- Excellent interpersonal skills.
Responsibilities
- Develop quality-assurance policies and procedures for medical-device and combination-product regulations in support of business objectives, functional strategies, and the Medical Device Center.
- Manage and oversee interrelated medical-device activities, including design control, with Research and Development, Manufacturing Science and Technology, Supply Chain, Program Management, Commercial, Medical, Pharmacovigilance, and Regulatory Affairs.
- Coordinate quality-system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates.
- Implement the quality system for medical devices and combination products in compliance with corporate, division, and site policies.
- Support new-product introduction for pharmaceutical products, medical devices, and combination products, and support design changes to existing devices and combination products.
- Oversee training on revised quality-system policies and procedures for medical-device and combination-product quality operations.
- Represent AbbVie in external industry groups where appropriate.
- Work with the Medical Device Centre, Regulatory Affairs, R&D, and Operations Quality Management to consolidate quality oversight of medical devices and combination products.
- Work with the director and department to achieve related goals and strategic initiatives.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
