Job Information
AbbVie Senior Manager, Quality Control Laboratory Operations in Worcester, Massachusetts
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 at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
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.
Qualifications
Qualifications
Minimum Bachelor’s Degree required preferably in Physical or Life Sciences, Pharmacy, or Engineering; Master’s Degree or PhD preferred.
Certified Quality Engineer or formal training in quality engineering or statistics is preferred
8+ years of combined experience in Manufacturing, QA, QC in pharmaceutical, biologics, device or chemical industry
4+ years of supervisory/technical leadership experience
Must have a basic understanding and working knowledge of the physical and chemical characteristics of the products, including raw materials, manufactured at the plant.
Must be familiar with use of statistical quality systems, electronic document management and laboratory information management.
Must also be familiar with Quality policies as well as cGMP and other regulatory requirements.
Must have effective people management and communication skills necessary to supervise those reporting directly or through subordinates as well as establish and maintain effective working relationships among other key individuals in manufacturing, materials management, engineering, product development, Quality Systems, Product QA, Quality Control, Information Systems and Regulatory Affairs and must demonstrate sound judgment in evaluating and acting on day-to-day situations.
Strong communication Skills, both oral and written
Must be experienced and demonstrate 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.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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 we 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.
This job is eligible to participate in our long-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 employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable 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 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.
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