Job Description

The Senior Manager, Quality provides leadership and direction to the Quality Function they are responsible for within Operations. This Sr. Manager role is responsible for the effective implementation of AbbVie Quality Systems for which they are responsible for. This could include: Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation of product and processes, 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 plant and/or strategic initiatives. Expectations that the professional will maintain high quality levels on all products while achieving high efficiency.

Responsibilities:

Responsible for various aspects of quality assurance and quality control related to products produced at the plant.  This will be at a large plant with high volume, high level of product complexity including multiple products at the site and may have 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 site. Ensures that product within the plant is consistently manufactured in conformance with corporate Quality requirements and all applicable regulatory requirements.

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.

Provides regulatory and technical guidance to all departments in the plant and can be the SME for all AbbVie plants. Communicates with executive level for Quality Management Review, Quality Initiatives, etc.

Incumbent is responsible for quality decisions related to all aspects of the plant operation 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.

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 for various aspects of quality assurance and quality control related to products produced at the plant.  This will be at a large plant with high volume, high level of product complexity including multiple products at the site and may have 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 site. Ensures that product within the plant is consistently manufactured in conformance with corporate Quality requirements and all applicable regulatory requirements.

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.

Provides regulatory and technical guidance to all departments in the plant and can be the SME for all AbbVie plants. Communicates with executive level for Quality Management Review, Quality Initiatives, etc.

Incumbent is responsible for quality decisions related to all aspects of the plant operation 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.

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.

Responsible for various aspects of quality assurance and quality control related to products produced at the plant.  This will be at a large plant with high volume, high level of product complexity including multiple products at the site and may have 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 site. Ensures that product within the plant is consistently manufactured in conformance with corporate Quality requirements and all applicable regulatory requirements.

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.

Provides regulatory and technical guidance to all departments in the plant and can be the SME for all AbbVie plants. Communicates with executive level for Quality Management Review, Quality Initiatives, etc.

Incumbent is responsible for quality decisions related to all aspects of the plant operation 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.

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.