Manager, Quality Control Laboratory

Ensures quality control and quality assurance compliance across the manufacturing site. Serves as an integral member of site leadership team with a focus on ensuring quality system requirements are achieved. Leads the site quality control unit and serves as the primary backup to the QA Site Director.

Responsibilities

• Manages the Quality Control (QC) laboratory including direct reports and budgetary responsibilities
• Member of the Laboratory Center of Excellence (COE)
• Serves as the standalone laboratory systems and site Maximo administrator
• Reviews and approves raw materials and commodities including ERP approval
• Exception Report (ER) investigation writing review and approval including ensuring effective CAPAs
• Qualification and validation protocol writing review and approval
• Actively participates in Periodic Validation Reviews Annual Product Reviews internal audits and process data reviews
• Provides front room and laboratory SME support during regulatory agency and internal inspections
• Manages change related to compendia supplier/service provider notifications material specifications analytical test methods test method validation SOPs batch records and site service requests
• Leads the implementation of Quality-related projects including metrics

Qualifications :

• Bachelors degree with 10 years of pharmaceutical Quality experience (preferably in QC) or an equivalent combination of education and experience

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 thisposting 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 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 commissionincentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless anduntil 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