Senior Manager, Quality Control

As the manager of the QC Laboratory organization, you will have the opportunity to lead a team of supervisors and analysts. You will be responsible for overseeing various laboratory operations, including Analytical Laboratory Operations, Raw Material/ In-Process Laboratory Operations, Laboratory Support Operations, and Laboratory Continuous Improvement/Compliance Operations.

In this role, you will play a crucial part in ensuring the GMP method performance of analytical chemistry and molecular-based assays. You will also be responsible for establishing GMP procedures required for laboratory operations. Your expertise will contribute to the readiness of QC in-process, release, and stability test methods used for drug substances and drug products.

We are looking for a driven and enthusiastic individual who is comfortable multitasking and working independently. You should have a passion for Quality Control and compliance, along with the ability to collaborate cross-functionally on various aspects of the platform.

If you are ready to take on this exciting opportunity and make a significant impact in the field of Quality Control, we encourage you to apply. Join our Quality Control team and be a part of a dynamic and innovative organization.

Responsibilities:

• Manage a team of Supervisors and Lab Analysts. Is responsible to 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 people issues without direct supervision.
• Plan and coordinate the testing and release of lab samples, project requests, in-process, raw materials.
• Evaluate any variables to identify and communicate the impact on the existing plan and incorporate in future laboratory plans.
• Ensure short range laboratory planning and scheduling, testing vs. capacity studies, backlog, delivery commitments.
• Manage coordination with the Production and Supply Chain Department to gain agreements on the activities needed to support production schedule execution.
• Responsible to measure people performance against the testing schedule to deliver the information to the supervisors to improve people performances.
• 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.

• 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, Sample Manager LIMS.
• Ability to interact and establish positive interaction with internal/external customers.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s 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.