Quality Assurance Manager, Chemistry

Seeking a Quality Assurance Manager of Chemistry to own batch certification and product release. In this role, you'll provide the final quality review and disposition of chemistry testing data supporting release of compounded and pharmaceutical products, making sure every analytical result, investigation, and piece of documentation meets cGMP, USP, and FDA expectations before the product goes out the door.

You'll sit at the intersection of Quality Assurance and Chemistry QC, giving independent oversight of analytical data, holding the line on data integrity, and making sure every batch decision is scientifically sound, compliant, and ready for inspection. This is a strong fit for someone who combines deep analytical chemistry expertise with confident QA decision-making and hands-on batch disposition experience in a regulated environment.

Responsibilities:

Batch release and disposition

• Serve as QA approver for batch release, making final disposition decisions on in-process, finished product, and stability batches
• Assess product impact and patient risk on atypical or out-of-trend results, and hold batches until all data, deviations, and investigations are fully resolved

Chemistry data review and oversight

• Conduct independent QA review of analytical data (assay, impurities, stability, physical testing), verifying accuracy, traceability, and compliance with validated methods
• Critically evaluate analyst conclusions for scientific soundness

Investigations, deviations, and CAPA

• Review and approve OOS, OOT, deviations, and lab investigations affecting batch release, ensuring clear root cause, risk assessment, and effective CAPAs
• Partner with QC and QA teams to keep investigations timely and defensible; prevent premature release where outcomes are unresolved

Quality systems, compliance, and audit readiness

• Ensure adherence to cGMP, FDA guidance, and USP standards (<795>, <797>, <800>); review and approve related SOPs
• Serve as subject matter expert during regulatory inspections and client audits, defending disposition decisions and keeping documentation inspection-ready

Cross-functional collaboration

• Partner with Chemistry QC, Operations, Sample Management, and Client Services on batch priorities, release timelines, and quality decisions

Team leadership

• Lead QA staff supporting batch release, setting schedules to meet throughput and turnaround commitments
• Coach and mentor staff, and own performance management including goal setting and feedback

Qualifications:

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, or related discipline (advanced degree preferred)
• 7-10 years of QA/QC experience in a regulated pharmaceutical or compounding environment, including batch release and disposition
• Strong analytical chemistry expertise (HPLC/UPLC, GC, KF, UV-Vis, FTIR)
• 3-5 years of direct people leadership, with a track record of mentoring, performance management, and team development
• Experience with OOS investigations, deviations, CAPA, data integrity, and supporting FDA inspections/client audits
• Strong technical writing skills and experience with electronic QMS and LIMS systems

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