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Job description
Accentuate Staffing is partnering with a leading pharmaceutical company who is hiring for a Quality Release Manager. This is a direct hire opportunity, offering competitive pay and benefits, working onsite. The ideal candidate has strong leadership experience in pharmaceutical quality assurance, deep expertise in batch disposition and release, and a proven ability to operate in a cGMP-regulated manufacturing environment.
Responsibilities
Lead batch record review and final disposition (approve, reject, hold) of finished product batches in compliance with regulatory requirements
Oversee and manage the batch release review team, ensuring timely, accurate, and compliant product release
Coordinate cross-functional activities with Production, QC Chemistry, QC Microbiology, QA Investigations, Supply Chain, and Regulatory teams
Perform QA functional review of deviations, exceptions, and OOS investigations, ensuring scientifically sound and compliant outcomes
Maintain batch disposition records and report on key quality metrics, including release cycle times and KPIs
Support regulatory inspections, customer audits, and internal audits as the subject matter expert for batch release processes
Review and approve documentation supporting Annual Product Quality Reviews (APQRs)
Provide leadership, coaching, and mentoring to QA staff involved in batch review and release activities
Requirements
Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Microbiology, or related life science
10+ years of progressive pharmaceutical QA experience in a CGMP-regulated manufacturing environment
5+ years of leadership experience overseeing batch record review, batch disposition, and product release activities
Strong knowledge of CGMPs, GLPs, GDPs, and ALCOA+ data integrity principles
Experience supporting regulatory inspections and interacting with agencies such as FDA or other global health authorities
Proven experience reviewing deviations, investigations, and OOS results and familiarity with quality systems and document management systems (eQMS)
Experience in sterile or aseptic manufacturing environments preferred
SAP or similar ERP system experience preferred
Lean, Six Sigma, or quality certifications (ASQ, Greenbelt, etc.) are a plus
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Worksite address
raleigh, NC, 27601, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.