Quality Manager, Finished Goods Commercial

Titile: QA Manager, Finished Goods Commercial Employment Type: Contract Status: Accepting Candidates We are seeking a Quality Manager to provide oversight of quality activities supporting Finished Goods Commercial Product. This role will manage multiple department activities, troubleshoot complex quality issues, and work closely with business partners and external partners to support continued supply and compliance with regulatory requirements. Key Responsibilities Finished Goods Disposition & Batch Release Review Executed Batch Records (EBRs) for commercial packaging operations Review change controls against full lot genealogy and determine material compliance Evaluate Investigations, OOS, and Change Controls to support disposition decisions Perform batch release activities Quality & Investigation Support Provide quality guidance for root-cause analysis and product impact assessments Triage deviations, OOS, and OOT investigations and escalates as needed Ensure appropriate CAPA actions are identified Serve as QA assessor/approver on Commercial Change Controls CMO & External Partner Management Develop relationships with strategic external partners Lead Quality-to-Quality meetings with CMO partners Influence timely completion of CMO product release and Right First Time activities Assist with Quality Agreements and metrics generation Audit & Inspection Support Provide audit and inspection preparation support Provide back-room support as needed Support post-inspection activities Qualifications Bachelor’s degree in a scientific or allied health field 5+ years of relevant experience Strong knowledge of global GMP requirements governing oral drug products Knowledge of oral drug product manufacturing practices Experience with GMP/GDP regulations and manufacturing/testing risk management principles Strong root-cause analysis and problem-solving skills Preferred Qualifications Strong leadership skills in a high-throughput environment Experience leading cross-functional teams and projects Strong project management and continuous improvement skills Ability to make risk-based quality decisions independently Broad GxP knowledge across the product lifecycle Strong communication, collaboration, and influencing skills Experience supporting audits and inspections Strong attention to detail, flexibility, and sense of urgency #J-18808-Ljbffr