Senior Manager, Device Quality

Employer
AbbVie
Location
Lake County, Illinois, USA
Posted
Mar 23, 2018
Ref
1708733
Required Education
Bachelors Degree
Position Type
Full time

Purpose:

Responsible for supporting activities for Combination Products, Pharmaceutical products and medical devices. This role will support the strategic direction to ensure business objectives are met to support and sustain the Combination Products, Pharmaceutical products, and medical devices. Complete quality assurance activities to develop, implement, and sustain required device regulations to comply with global medical device and Combination Product Regulations and assure proper integration and support of device regulations, drug regulations, and as appropriate, biologics regulations.

Responsibilities:

• 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, Pharmacoviligance, and Regulatory Affairs. Coordinate quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates.
•Responsible for implementing and maintaining the effectiveness of the quality system for medical devices and combination productions 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 implementation and management of training programs for medical devices and combination products.
•Represent AbbVie on external industry groups where appropriate.
•Represent AbbVie as the medical device and combination products Quality Assurance subject matter expert during internal and external regulatory inspections. May conduct activities associated with the internal audit program. Support third party manufacturers and supplier programs where suppliers provide key components or constituent parts to medical devices or combination products.
•Coordinate the Medical Device Center Management Review. Act as Medical Device Center Quality Plan Coordinator.
•Works with the director and with the department to achieve related goals and strategic initiatives.

Qualifications: • 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, Pharmacoviligance, and Regulatory Affairs. Coordinate quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates.
•Responsible for implementing and maintaining the effectiveness of the quality system for medical devices and combination productions 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 implementation and management of training programs for medical devices and combination products.
•Represent AbbVie on external industry groups where appropriate.
•Represent AbbVie as the medical device and combination products Quality Assurance subject matter expert during internal and external regulatory inspections. May conduct activities associated with the internal audit program. Support third party manufacturers and supplier programs where suppliers provide key components or constituent parts to medical devices or combination products.
•Coordinate the Medical Device Center Management Review. Act as Medical Device Center Quality Plan Coordinator.
•Works with the director and with the department to achieve related goals and strategic initiatives.


Equal Opportunity Employer Minorities/Women/Veterans/Disabled