Quality Senior Manager
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 across 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 position 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. The role manages a budget and is accountable for maintaining high product quality while driving operational efficiency. It provides quality and regulatory leadership for complex, high-volume operations involving products such as biologics, medical devices, CRT, cold-chain, and frozen products. The position includes 25% travel.
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, medical 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 teams through subordinates 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 professionals responsible for quality assurance for products distributed from AbbVie-owned facilities and third-party logistics providers.
- Provide quality and regulatory compliance leadership for complex operations involving high volumes and products such as 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 and applicable regulatory requirements.
- Manage, organize, train, and supervise the Quality team.
- 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 Quality unit’s annual operating budget.
- Make quality decisions related to distribution and logistics, including change management, process management, quality systems, and management review, to ensure compliance with cGMP, FDA, EU, DEA, and other applicable requirements.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- 401(k).
- Eligible to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
