Quality Senior Manager

About the role

Purpose

The Senior Manager, Quality provides leadership and direction for the Quality function within Operations. This role is responsible for the effective implementation of AbbVie quality systems within their area of responsibility, including quality oversight of AbbVie-owned warehouses (AP5, AP15, and AP32), the 3PL network, transportation service providers, and quality-relevant suppliers supporting distribution and logistics.

Accountabilities also encompass training, regulatory compliance, quality planning, and strategic initiatives. The Senior Manager, Quality leads a team of Quality professionals responsible for compliance and quality oversight across AbbVie-owned warehouses, service providers, and strategic initiatives. This position manages a budget and is accountable for maintaining high product quality while driving operational efficiency.

Responsibilities

• Oversee a team of Quality professionals responsible for quality assurance related to the distribution and logistics of products shipped from AbbVie-owned facilities and third-party logistics providers.
• Provide quality and regulatory compliance leadership for complex operations with high volume and product complexity, 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 are aligned 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 required 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 related to all aspects of distribution and logistics - including change management, process management, quality systems, and management review - to ensure compliance with cGMP, FDA, EU, DEA, and other applicable regulatory requirements.

25% Travel*

Qualifications & Requirements

• *Minimum Bachelor's Degree required preferably in Physical or Life Sciences, Pharmacy, or Engineering; Master's Degree or PhD preferred.

• *Certified Quality Engineer or formal training in quality engineering or statistics is preferred
• *8+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical, biologics, device or chemical industry
• *4+ years of supervisory/technical leadership experience
• *Must have a basic understanding and working knowledge of the physical and chemical characteristics of the products, including raw materials, manufactured at the plant.
• *Must be familiar with use of statistical quality systems, electronic document management and laboratory information management.
• *Must also be familiar with Quality policies as well as cGMP and other regulatory requirements.

*Must have effective people management and communication skills necessary to supervise those reporting directly or through subordinates as well as establish and maintain effective working relationships among other key individuals in manufacturing, materials management, engineering, product development, Quality Systems, Product QA, Quality Control, Information Systems and Regulatory Affairs and must demonstrate sound judgment in evaluating and acting on day-to-day situations.

*Strong communication Skills, both oral and written.

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 employee 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.