About this role
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 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 required
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Continuous walking for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
Bachelor’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. 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 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.
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 anduntil 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html