Device Quality Senior Manager

AbbVie Inc.; Chippewa Falls (WI); Hybride; USD 120 000 - 160 000; Plein temps

Résumé du poste

AbbVie Inc. is seeking a senior quality system professional to support medical device and combination product quality assurance. The role develops QA policies, coordinates cross-functional activities with R&D, manufacturing, supply chain, regulatory affairs, and leads training and continuous improvement initiatives.

Responsibilities include design control, regulatory compliance across ISO, CFR and EU standards, and representing AbbVie in external industry groups as needed.

Qualifications

• Bachelor’s degree in chemistry, pharmacy, biology, microbiology, engineering or related technical field.
• 8+ years of quality assurance or quality system oversight experience; device regulation knowledge preferred.
• Experience leading cross-functional teams and driving project results.
• Knowledge of ISO, US CFR and EU medical device regulations; regulatory agency interface preferred.
• Ability to assess impact of quality system changes across divisions.

Responsabilités

• Develop, implement and sustain quality policies and procedures for medical devices and combination products.
• Oversee design control with R&D, Manufacturing Science & Technology, supply chain and regulatory affairs.
• Coordinate quality system elements, training, continuous improvement, and cross-site support.
• Represent AbbVie in external industry groups when appropriate.
• Consolidate quality oversight across medical device and combination product lines.

Connaissances

Quality Assurance

Regulatory Knowledge

Cross-functional Leadership

Communication Skills

Formation

Bachelor’s Degree in Science/Engineering

Description du poste

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 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.

• 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 or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html