Senior Manager, Quality Control

1 month ago

Massachusetts, United States AbbVie Full time

Company Description

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 Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description

The Quality Control (QC) Senior Manager is responsible for management of the QC Laboratory organization which may include management of Supervisors and Analysts. This position manages a business unit consisting of one of the following disciplines: Analytical Laboratory Operations, Raw Material/ In-Process Laboratory Operations, Laboratory Support Operations, and Laboratory Continuous Improvement/Compliance Operations.

The Quality Control Sr. Manager will be responsible for QC laboratory operations and GMP method performance of analytical chemistry and molecular based assays. We are searching for a driven, enthusiastic and self-motivated individual who is comfortable multitasking and working both independently and cross-functionally on various aspects of the platform. This position will join the Quality Control team and assist in establishing GMP procedures required for GMP laboratory operations as well as manage and perform GMP method performance to ensure readiness of QC in-process, release and stability test methods used for drug substances and drug products.

Responsibilities:

Manage a team of Supervisors and Lab Analysts.Responsible for hiring, leading, training, and developing team members to ensure that the department has the appropriate talent and level of performance to meet business objectives.Assist team members in problem solving.Identify and resolve people issues without direct supervision.Plan and coordinate the testing and release of lab samples, project requests, in-process, and raw materials.Evaluate any variables to identify and communicate the impact on the existing plan and incorporate it in future laboratory plans.Ensure short range laboratory planning and scheduling, testing vs. capacity studies, backlog, and delivery commitments.Manage coordination with the Production and Supply Chain Department to gain agreements on the activities needed to support production schedule execution.Responsible for measuring peoples performance against the testing schedule to deliver the information to the supervisors to improve performance.Manage customer and TPL communications regarding testing status and ensure the samples tested outside of AbbVie QC laboratory are on target.Coordinate implementation and enhancements to the lab planning tools.Accountable for on-time delivery of materials for testing, and for the release of lab dates to customers.
Qualifications
Qualifications:Required - BS degree in Science or equivalent and 8+ years of relevant experience OR

Master's degree in Science or equivalent and 6+ years of relevant experience

Preferred - PhD in Science or equivalent and 3+ years of relevant experience.Experience in Quality Control roles supporting GMP testing/manufacturing.Must be experienced and demonstrate a high level of technical skill in technical lab operations and good understanding of related business.Experience with HPLC/UPLC-based assays and ELISA is a must. Desire to expand analytical expertise highly preferred.Experience with Empower, SoftMax Pro software, and Sample Manager LIMS.Ability to interact and establish positive interaction with internal/external customers.
Additional Information
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, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit

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