Senior Manager, Lab Services

Job Description

The Senior Manager Quality provides leadership and direction to the Quality Control Laboratories they are responsible for within Operations. This Sr. Manager role is responsible for the effective implementation of AbbVie Quality Systems. This could include: Incoming Quality Assurance of drugs and packaging materials Validation of instruments test methods and test method transfers 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 Quality Control Labs 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 manufacturing site with high volume high level of product complexity including multiple products at the site and has 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 Quality Control Labs.
• Manages a team of quality professionals. Directly responsible for the effective organization administration training and supervision of their functional area.
• Provides regulatory and technical guidance to all departments in the Quality Control Labs and can be the SME.
• Communicates with executive level for Quality Management Review Quality Initiatives etc.
• Responsible for the development and administration of the annual operating budget and annual capital budget they are responsible for.
• Incumbent is responsible for quality decisions related to all aspects of the Quality Control Labs operation including facility design and laboratory controls and to ensure that the area of their responsibility meets all cGMP FDA EU DEA and other regulatory requirements.
• Incumbent is responsible for quality decisions related to all aspects of the Quality Control operations 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.

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Qualifications :

• Minimum Bachelors Degree required preferably in Physical or Life Sciences Pharmacy or Engineering; Masters Degree or PhD preferred.
• 8 years of combined experience in Manufacturing QA QC R&D in pharmaceutical biologics device or chemical industry
• 4 years of supervisory/technical leadership experience
• 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

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 thetime of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand 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. 

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 anybonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys soleand absolute discretion unless and until paid and may be modified at the Companys 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time