Quality Senior Manager

AbbVie•Mettawa, IL

7h•$124,500 - $236,500

About The Position

The Senior Manager, Quality provides leadership and direction to the Quality Function for which they are responsible within Operations and oversees effective implementation of the applicable AbbVie Quality Systems. The function may include incoming quality assurance for drugs and packaging materials, manufacturing quality assurance, product and process validation, quality engineering, quality control, training, regulatory compliance, quality planning, product quality, and strategic initiatives. The role manages a budget and leads quality professionals responsible for compliance and quality oversight for a plant and/or strategic initiatives, maintaining high product quality while achieving high efficiency. The position covers a large, high-volume plant with complex products and potentially multiple production types, such as API, finished goods, biologics, packaging, and devices. The Senior Manager serves as the decision-making authority for job-specific aspects of the site Quality and Regulatory compliance program, provides regulatory and technical guidance across plant departments, and may serve as a subject matter expert for all AbbVie plants. The role communicates with executive leadership on Quality Management Review and Quality Initiatives, and develops and administers the annual operating budget for the responsible Quality Unit. Quality decisions encompass plant operations, including facility design, laboratory controls, and product specifications, ensuring applicable cGMP, FDA, EU, DEA, and other regulatory requirements are met.

Requirements

Bachelor’s degree required, preferably in Physical or Life Sciences, Pharmacy, or Engineering.
At least 8 years of combined experience in Manufacturing, QA, QC, or R&D in the pharmaceutical, biologics, device, or chemical industry.
At least 4 years of supervisory or technical leadership experience.
Basic understanding and working knowledge of the physical and chemical characteristics of products, including raw materials, manufactured at the plant.
Familiarity with statistical quality systems, electronic document management, and laboratory information management.
Familiarity with Quality policies, cGMP, and other regulatory requirements.
Effective people management and communication skills to supervise direct reports or subordinate teams and maintain effective working relationships across relevant functions.
Sound judgment in evaluating and acting on day-to-day situations.
Strong oral and written communication skills.

Nice To Haves

Master’s degree or PhD.
Certified Quality Engineer credential or formal training in quality engineering or statistics.

Responsibilities

Oversee quality assurance and quality control related to products produced at a large, high-volume, high-complexity plant, potentially covering multiple products and production types.
Serve as the decision-making authority for job-specific aspects of the site's Quality and Regulatory compliance program.
Ensure plant products are consistently manufactured in conformance with corporate Quality requirements and applicable regulatory requirements.
Organize, administer, train, and supervise the assigned functional area and manage a team of quality professionals.
Provide regulatory and technical guidance to plant departments and serve as a subject matter expert for AbbVie plants as applicable.
Communicate with executive-level stakeholders regarding Quality Management Review, Quality Initiatives, and related matters.
Develop and administer the annual operating budget for the responsible Quality Unit.
Make quality decisions involving plant operations, including facility design, laboratory controls, and product specifications, and ensure applicable cGMP, FDA, EU, DEA, and other regulatory requirements are met.