Senior Manager, Quality

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, and neuroscience—and products and services in our Allergan Aesthetics portfolio.

About the role

The Senior Manager, Quality provides leadership and direction to the Quality Function within Operations. This role is responsible for the effective implementation of AbbVie Quality Systems, which may include:

• Incoming Quality Assurance of drugs and packaging materials
• Manufacturing Quality Assurance
• Validation of product and processes
• Quality Engineering
• Quality Control
• Training
• Regulatory Compliance
• Quality Planning
• Product Quality and strategic initiatives

The Senior Manager of Quality manages a budget and leads a team of quality professionals responsible for compliance and quality oversight for the plant and/or strategic initiatives. The role requires maintaining high quality levels on all products while achieving high efficiency.

Responsibilities

• Oversee various aspects of quality assurance and quality control related to products produced at a large, high-volume plant with high product complexity, including multiple products and types of production (API, Finished Goods, Biologics, Packaging, Device, etc.).
• Serve as the decision-making authority on job-specific aspects of the Quality and Regulatory compliance program for the site.
• Ensure products are consistently manufactured in conformance with corporate Quality requirements and all applicable regulatory requirements.
• Manage a team of quality professionals, including organization, administration, training, and supervision of their functional area.
• Provide regulatory and technical guidance to all departments in the plant and act as the Subject Matter Expert (SME) for all AbbVie plants.
• Communicate with executive leadership for Quality Management Review, Quality Initiatives, and other strategic discussions.
• Develop and administer the annual operating budget for the Quality Unit.
• Make quality decisions related to all aspects of plant operation, including facility design, laboratory controls, and product specifications, ensuring compliance with cGMP, FDA, EU, DEA, and other regulatory requirements.

Qualifications

• 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.
• 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 systems.
• Knowledge of Quality policies, cGMP, and other regulatory requirements.
• Effective people management and communication skills to supervise teams and collaborate with key individuals in manufacturing, materials management, engineering, product development, Quality Systems, Product QA, Quality Control, Information Systems, and Regulatory Affairs.
• Strong oral and written communication skills.

Benefits

• Comprehensive package including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Eligibility to participate in long-term incentive programs.