Job TitleEnsures 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.ResponsibilitiesManages the Quality Control (QC) laboratory including direct reports and budgetary responsibilitiesMember of the Laboratory Center of Excellence (COE)Serves as the standalone laboratory systems and site Maximo administratorReviews and approves raw materials and commodities including ERP approvalException Report (ER) investigation, writing, review, and approval including ensuring effective CAPAsQualification and validation protocol writing, review, and approvalActively participates in Periodic Validation Reviews, Annual Product Reviews, internal audits, and process data reviewsProvides front room and laboratory SME support during regulatory agency and internal inspectionsManages change related to compendia, supplier/service provider notifications, material specifications, analytical test methods, test method validation, SOPs, batch records, and site service requestsLeads the implementation of Quality-related projects including metricsSignificant Work Activities:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is requiredContinuous standing for prolonged periods (more than 2 consecutive hours in an 8 hr day) is requiredContinuous walking for prolonged periods (more than 2 consecutive hours in an 8 hr day) is requiredFrequent to continuous computer usage (greater or equal to 50% of the workday) is requiredQualificationsBachelor's degree with 10 years of pharmaceutical Quality experience (preferably in QC).Previous experience leading teams in highly desired.Strong background in Quality/ QC within the Pharmaceutical and/ or Biotechnology industry.Excellent oral and written communication skills required with the capability of clearly presenting and justifying quality requirements.Key leadership competencies include cultural awareness, relationship building, ability to influence at all levels of the organization, teamwork building, sound judgment and the ability to make difficult decisions, often at short notice.Additional InformationThe 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 long-term incentive programs.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.