Quality Systems Manager

AbbVie•North Chicago, IL

2d•$109,500 - $208,500

About The Position

The Quality Systems Manager provides quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, cosmetics, combination products, and biologics. The role supports strategic direction and business objectives, translating strategy into tactical objectives and delivering strategic plans and regulatory updates. Areas of responsibility may include supplier qualification and approval, supplier risk management, supplier change management, and Approved Supplier List (ASL) governance. The position ensures that product-, process-, and system-related quality activities—from raw material inspection through shipment of final product—comply with corporate and governmental regulations. The manager supports the integration of applicable quality regulations, leads quality documentation work, maintains effective quality systems, and coordinates quality activities, training, and continuous improvement across functions, plants, and affiliates. The role works with internal and external partners and cross-functional teams to support new product introductions, changes to existing products, regulatory and internal audits, and ongoing improvements to quality systems and procedures.

Requirements

Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or another technical or scientific area is preferred.
At least 8 years of experience in quality assurance, quality oversight, or relevant experience.
Experience leading technical professionals and cross-functional teams.
Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, and Manufacturing Operations.
Knowledge of products, processes, equipment, and facilities related to pharmaceutical, biological, or device products.
Knowledge of QA systems and GMP compliance requirements, including regulations and standards affecting device, biologics, and pharmaceutical products.
Ability to work both independently and in a team setting, work with manager guidance, and manage one’s own time.
Strong oral communication skills with all levels of management and strong written communication skills.
Ability to lead medium- to larger-sized projects of increasing complexity and size to deliver tactical results supporting strategic initiatives.

Nice To Haves

Excellent interpersonal skills.

Responsibilities

Ensure proper integration and support of quality regulations for drugs, biologics, cosmetics, devices, and/or combination products.
Lead project teams in planning, preparing, reviewing, and approving quality documentation.
Implement and maintain the effectiveness of quality systems for drugs, biologics, cosmetics, devices, and/or combination products, including compliance with corporate policies, processes, and procedures.
Design effective quality systems, procedures, and processes with cross-functional teams to support compliance and efficiency; prepare and present data during regulatory and internal audits as needed.
Manage and oversee interrelated activities, including design control, with R&D, Manufacturing Science and Technology (MS&T), 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.
Support new product introduction for pharmaceutical products, medical devices, and combination products, and support design changes to existing medical devices and combination products.
Work with internal and external partners to develop quality-system and procedural best practices.
Assess compliance with processes and regulations, identify potential gaps, and mitigate issues and implement quality-system improvements.
Oversee implementation and management of training and education programs covering aspects of quality assurance.