Quality Laboratory Manager - AbbVie : Job Details

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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

PurposeThe Quality Laboratory Manager will ensure qualitycontrol and quality assurance compliance across our Waco, Texas manufacturing site and serve as an integral member of the site leadership team. This role will have a large focus on ensuring quality system requirements are achieved, as well as lead the site quality control unit and serve as primary backup to the QC Site Director.This role manages and provides strategic direction to laboratory business units consisting of: Finished Goods Laboratory Operations, Raw Material/In-Process Laboratory Operations, and Laboratory Continuous Improvement/Compliance Operations.

Responsibilities

• Manage a large team of lab supervisors and analysts. Hire, lead, and develop team members to ensure that the department has the appropriate talent and level of performance to meet business objectives. Assure training and development of subordinates. Assist subordinates in problem solving. Identify and resolve personnel issues without direct supervision.
• Assure conformance to all government and corporate regulations. Responsible to develop, provide, defend, persuade Corporate/Plant practices with outside organizations. Routinely meet with regulators (FDA & EU) and customers to ensure no interruption in business due to compliance issues.
• Responsible for meetingproduction objectives within planned budgets. Provideinput to management for resources needed to construct budget, updates, and changes in financial plan. Managearea supplies and equipment within budgeted amounts.
• Establish and execute plans and commitments consistent to Development, Manufacturing, Customers and Business needs.
• Conceive, design, conduct, and advance independent scientific research activities per strategic business needs. Ensure research activities/projects are on track per business needs and established timeline.
• Develop, negotiate, finalize timeline and cost estimates for projects and/or service contracts to support business operations and/or external customers needs.
• Conceive, design, and executeprojects related to the strategic needs of the business operations.
• Provide timely testing or execution of in-process, raw materials, intermediates, API, finished goods, continuous improvement initiatives, QA training, laboratory equipment validation and stability depending on area of responsibility.
• Applyadvanced technical writing skills to prepare project protocol, and final reports to support product registration and/or business needs.
• Coordinateand manage communication/negotiation with external contacts and customers to develop and foster positive business relationships. Providestrategic direction for area of operation and ensuretactical objectives are met.

• Bachelor's degreein Science is required + 8 years of relevant experience OR Master's degree in Science + 6 years of relevant experience. Preferred - PhD in Science + 4 years of relevant experience.
• Must be experienced and demonstrate high level of technical skill in technical lab operations and good understanding of related business.
• Related knowledge in Product Quality, Quality Control Lab Operation and Regulatory requirements is required.
• Ability to work independently to meet operational goals and business needs.
• Ability to develop, design, execute and manage complex research programs.
• Ability to make operational and business decisions with minimum direction from immediate manager. Must have knowledge and skill in personnel management, and develop and managing budget.
• Ability to interact and establish positive interaction with internal/external customers.
• Shows broad understanding of the issues relevant to technical/science and business.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible to participate in our short-term incentiveprograms.

• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie 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.

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