Senior Manager, Lab Services

Company Description

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.

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. Responsibilities 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 lead a team of quality professionals who are responsible for compliance and quality oversight for the Quality Control Labs and/or strategic initiatives. Expectations are 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, including high volume, multiple product types (API, Finished 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, responsible for organization, administration, training and supervision of their functional area.
• Provides regulatory and technical guidance to all departments in the Quality Control Labs and may be the SME.
• Communicates with executive level for Quality Management Review, Quality Initiatives, etcli>
• Develops and administers the annual operating budget and capital budget.
• Responsible for quality decisions related to all aspects of the Quality Control Labs operation including facility design, laboratory controls, ensuring compliance with cGMP, FDA, EU, DEA and other regulatory requirements.

• Minimum Bachelor’s Degree in Physical or Life Sciences, Pharmacy, or Engineering;
  Master’s 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.
• Familiar with statistical quality systems, electronic document management and laboratory information management.
• Familiarity with Quality policies and cGMP and other regulatory requirements.
• Strong people management and communication skills; ability to supervise and establish effective working relationships across manufacturing, materials management, engineering, product development, Quality Systems, Product QA, Quality Control, Information Systems, and Regulatory Affairs.
• Strong communication skills, both oral and written.

• 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 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 short‑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 employer remains in the Company’s sole and absolute discretion until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.

US & Puerto Rico only - to learn more, visit

US & Puerto Rico applicants seeking a reasonable accommodation,