Device Quality Senior Manager

AbbVie; North Chicago (IL); Sur place; USD 125 000 - 237 000; Plein temps

Résumé du poste

AbbVie Inc. is seeking an experienced Quality Assurance leader to support the medical device and combination product business.

The role drives the design, implementation, and sustainment of required device regulations across global operations, partnering with R&D, Manufacturing Science, Supply Chain, Regulatory Affairs, and other functions. Responsibilities include developing QA policies, overseeing training, and coordinating cross-functional activities to ensure compliance with corporate and

Qualifications

• Bachelor's degree and 8+ years in quality assurance or quality system oversight.
• Knowledge of device, biologics and pharma regulations; ISO, US CFR, EU rules.
• Experience leading cross-functional teams and solving complex problems.
• Strong communication and regulatory interface abilities.

Responsabilités

• Develop and implement quality assurance policies and procedures for medical devices and combination products.
• Oversee quality system elements, training, continuous improvement, and cross-functional support across sites.
• Ensure compliance with corporate, division, and site policies for device quality systems.
• Support new product introductions and design changes for medical devices and combination products.
• Manage training for revised quality policies and procedures for medical devices.
• Represent AbbVie on external industry groups as appropriate.
• Coordinate consolidation of quality oversight with Regulatory Affairs, R&D, and Operations Quality Management.
• Collaborate with leadership to achieve goals and strategic initiatives.

Connaissances

Quality Assurance

Leadership

Regulatory knowledge

Cross-functional teams

Problem solving

Formation

Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical or scientific area

Description du poste

• Compensation: USD 124,500 - USD 236,500 - yearly

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

Responsible for supporting quality system integration activities for the Medical Device and Combination product business. This role will support the strategic direction to ensure business objectives are met to support and sustain the Combination Projects 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.

• 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 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 management of training for revised quality system polices 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.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.