Chemistry Quality Assurance Manager

Position Overview

The Chemistry Quality Assurance Manager serves as the QA authority for batch certification and product release. This role is responsible for the final quality review and disposition of chemistry testing data supporting batch release for compounded and pharmaceutical products, ensuring all analytical results, investigations, and documentation meet cGMP, USP, and FDA expectations prior to release.

This position bridges Quality Assurance and Chemistry QC providing independent oversight of analytical data, enforcing data integrity standards, and ensuring all batch-related decisions are scientifically justified, compliant, and inspection-ready. The ideal candidate brings deep expertise in analytical chemistry, strong QA decision-making capability, and demonstrated experience in batch disposition within regulated environments.

Primary Responsibilities

Batch Release & Disposition

• Serve as the QA approver for batch release, ensuring all required chemistry testing, documentation, and investigations are complete and compliant
• Perform final disposition decisions for in-process, finished product, and stability batches
• Assess product impact and patient risk associated with atypical or out-of-trend results
• Ensure no product is released until all data, deviations, and investigations are fully resolved and approved

Chemistry Data Review & Oversight

• Conduct independent QA review of analytical data, including assay, impurities, stability, and physical testing results
• Verify accuracy, completeness, and traceability of raw data, calculations, and reported results
• Ensure analytical methods, system suitability, and test execution meet validated and regulatory standards
• Provide critical evaluation of analyst conclusions, ensuring scientific soundness and compliance

Investigations, Deviations & CAPA

• Review and approve OOS, OOT, deviations, and laboratory investigations impacting batch release
• Ensure investigations establish clear root cause, include appropriate risk assessments, and define effective CAPAs
• Partner with QC and QA teams to ensure investigations are timely, thorough, and defensible
• Prevent premature batch release where investigation outcomes remain unresolved

Quality Systems & Compliance

• Ensure adherence to cGMP, FDA guidance, and USP standards (<795>, <797>, <800>) for batch release testing
• Review and approve SOPs related to data review, batch disposition, and analytical processes
• Support continuous improvement of QMS processes governing batch release and testing workflows

Cross-Functional Collaboration

• Partner with Chemistry QC, Operations, Sample Management, and Client Services to align on batch priorities and release timelines
• Provide QA guidance on analytical execution, investigation strategy, and release readiness
• Communicate batch-related quality decisions to internal stakeholders and clients as needed

Audit & Inspection Readiness

• Serve as subject matter expert during regulatory inspections and client audits for batch release and analytical QA
• Defend batch disposition decisions, investigation outcomes, and data review practices
• Ensure all batch documentation is inspection-ready, consistent, and compliant

Team Leadership

• Lead and manage QA staff supporting batch release, ensuring clear ownership and accountability for deliverables
• Establish daily and weekly scheduling to support throughput, turnaround times, and release commitments
• Provide hands-on coaching and mentoring to develop technical capability, decision-making, and QA judgment
• Drive a culture of accountability, responsiveness, and right-first-time execution
• Conduct performance management, including goal setting, feedback, and corrective coaching

Qualifications

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

Core Competencies

Batch Disposition & Product Release · Chemistry Data Review & Interpretation · cGMP & Regulatory Compliance · Investigation & Risk Assessment · Data Integrity & Documentation · Cross-Functional Influence · Audit & Inspection Readiness · Team Leadership & Accountability

Benefits
Company offers employee benefits like health, dental, life, and vision insurance, 401(k) with matching, and paid time off (PTO), alongside career growth in pharmaceutical microbiology, focusing on quality and collaboration.