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Job Description

The Manager, Quality Control provides oversight of a variety of analytical functions that occur in the QC department supporting validation, testing and reporting of in-process, release and stability samples. This role also ensures activities occur in an efficient and cGMP compliant manner. The role will have formal people management responsibilities.

Key Duties & Responsibilities

• Coordinates and facilities laboratory activities to meet commitments on-time
• Ensures assay readiness with adequate inventory of qualified reagents and trained analysts.
• Maintains QC lab in audit ready state with an eye on continuous improvement.
• Leads planning, coordination and/or review of method validations, method transfers and/or equipment qualification/requalification
• Assist in troubleshooting of analytical methods and/or equipment as required
• Authors, review, and/or approves data, SOPs, COAs, analytical methods, protocols and reports
• Monitor, track and publish lab metrics
• May be required to lead OOS/OOT investigations/deviations and to identify corrective actions to prevent re-occurrence

Required Knowledge/Skills

• Bachelor's Degree in science or related discipline with 8+ years of experience in pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience
• Previous managerial experience (people leader) in a QC or equivalent laboratory setting
• Strong knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections
• Strong knowledge of analytical methodologies such as flow cytometry, cell based assays, qPCR, ELISA, BACT, endotoxin and applying/interpretation of GMP requirements
• Effective communication skills, both verbal and written
• Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail

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