Quality Senior Manager

AbbVie•Mettawa, IL

17h•$124,500 - $236,500

About The Position

The Senior Manager, Quality provides leadership and direction for the Quality function within Operations. The role is responsible for implementing AbbVie quality systems within its area of responsibility, including quality oversight of AbbVie-owned warehouses (AP5, AP15, and AP32), the third-party logistics network, transportation service providers, and quality-relevant suppliers supporting distribution and logistics. The role also covers training, regulatory compliance, quality planning, and strategic initiatives. The Senior Manager leads a team of Quality professionals responsible for compliance and quality oversight across owned warehouses, service providers, and strategic initiatives. This position manages a budget and is accountable for maintaining high product quality while driving operational efficiency. The role provides quality and regulatory leadership for complex, high-volume operations involving products such as biologics, medical devices, CRT, cold-chain, and frozen products. It serves as the decision-making authority for job-specific aspects of quality and regulatory compliance across assigned sites, provides regulatory and technical guidance, and communicates with leadership about quality management reviews, initiatives, and issue resolution. The position develops and administers the Quality unit's annual operating budget and makes quality decisions across distribution and logistics to ensure compliance with applicable requirements, including cGMP, FDA, EU, and DEA requirements. Travel is 25%.

Requirements

Bachelor’s degree in Physical or Life Sciences, Pharmacy, or Engineering; a Master’s degree or PhD is preferred.
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 employees directly or through subordinates and maintain effective working relationships with relevant departments and key individuals.
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

Lead a team of Quality professionals overseeing quality assurance for distribution and logistics of products shipped from AbbVie-owned facilities and third-party logistics providers.
Provide quality and regulatory compliance leadership for complex operations involving high volumes and products including biologics, medical devices, CRT, cold-chain, and frozen products.
Serve as the decision-making authority for job-specific aspects of the quality and regulatory compliance program across assigned sites.
Ensure quality metrics and key performance indicators align with corporate quality requirements and applicable regulatory requirements.
Manage, organize, train, and supervise the Quality team to ensure effective functional performance.
Provide regulatory and technical guidance to departments and serve as a subject matter expert as needed.
Communicate with leadership regarding quality management reviews, quality initiatives, and issue resolution.
Develop and administer the annual operating budget for the Quality unit.
Make quality decisions concerning distribution and logistics, including change management, process management, quality systems, and management review, to ensure regulatory compliance.