Senior Manager, Lab Services

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This range is provided by Abb Vie. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Abb Vie'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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

$/yr - $/yr

The Senior Manager, Quality provides leadership and direction to the Quality Control Laboratories they are responsible for within Operations. This Sr. Manager role is responsible for the effective implementation of Abb Vie Quality Systems. This could include:
Incoming Quality Assurance of drugs and packaging materials, Validation of instruments, test methods, and test method transfers, Quality Engineering, Quality Control, Training, Regulatory Compliance, Quality Planning, Product Quality and strategic initiatives. The Sr. Manager of Quality would be expected to manage a budget and leads a team of quality professionals who are responsible for compliance and quality oversight for the Quality Control Labs and/or strategic initiatives.

Expectations that the professional will maintain high quality levels on all products while achieving high efficiency.

• Responsible for various aspects of quality assurance and quality control related to products produced at the plant. This will be at a manufacturing site with high volume, high level of product complexity including multiple products at the site and has the complexity of multiple types of productions (API, Fin Goods, Biologics, Packaging, Device, etc.).
• Represents the decision-making authority on job specific aspects of the Quality and Regulatory compliance program for the Quality Control Labs.
• Manages a team of quality professionals. Directly responsible for the effective organization, administration, training and supervision of their functional area.
• Provides regulatory and technical guidance to all departments in the Quality Control Labs and can be the SME.
• Communicates with executive level for Quality Management Review, Quality Initiatives, etc.
• Responsible for the development and administration of the annual operating budget and annual capital budget they are responsible for.
• Incumbent is responsible for quality decisions related to all aspects of the Quality Control Labs operation including facility design and laboratory controls and to ensure that the area of their responsibility meets all cGMP, FDA, EU, DEA and other regulatory requirements.
• Incumbent is responsible for quality decisions related to all aspects of the Quality Control operations including facility design, laboratory controls and product specifications and to ensure that the area of their responsibility meets all cGMP, FDA, EU, DEA and other regulatory requirements.

• Minimum Bachelor’s Degree required preferably in Physical or Life Sciences, Pharmacy, or Engineering;
  Master’s Degree or PhD 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 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…