Device Quality Senior Manager

• Areas of direct responsibility include development of Quality Assurance policies and procedures for medical devices and Combination Product regulations that support the AbbVie business objectives, functional area strategies, and the Medical Device Center.
• Manage and oversee the interrelated function activities related to medical device management 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.
• Responsible for implementing the quality system for medical devices and combination products including compliance with Corporate, Division, and Site policies.
• Support new product introduction for pharmaceutical products, medical devices, or combination products. Support design changes to existing medical devices and combination products.
• Oversee the management of training for revised quality system policies and procedures for the medical device and combination products quality operation.
• Represent AbbVie on external industry groups where appropriate.
• In association with the Medical Device Centre, Regulatory Affairs, R&D & Operations Quality Management, manage the consolidation of the quality oversight of medical device and combination products.
• Works with the director and with the department to achieve related goals and strategic initiatives.

Qualifications

• Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical or scientific area.
• At least 8 years' experience with quality assurance and/or quality system oversight. Device regulation experience preferred.
• Leadership of other technical professionals and experience in leading cross-functional teams with results orientation. Skilled in the strategy development, initiation, selection, coordination, and management of projects and have the ability to solve unique problems.
• Knowledge of regulations and standards affecting devices, biologics, and pharma products. Knowledge of International Organization for Standardization (ISO) standards, US Code of Federal Regulations, and the EU regulations. Previous experience with regulatory agency interface preferred.
• Understands impact of specific area system changes to other quality systems as well as changes within division requirements and impact to specific area of control and able to adjust accordingly.
• Conflict resolution skills including persuasive management techniques required. Strong oral and written communication skills needed. Excellent interpersonal skills a plus.