Position SummaryThe Senior Manager, Quality Control - Analytical Support & Investigations is a senior technical leadership role responsible for providing investigation oversight and analytical problem-solving support across the Quality Control organization. The position serves as a central QC resource for Out-of-Specification (OOS), Out-of-Trend (OOT), laboratory deviations, atypical results, invalid assays, and other significant laboratory events associated with QC testing.
The Senior Manager is an individual contributor and partners closely with QC Chemistry, QC Microbiology, Raw Materials, Quality Assurance, Manufacturing, Analytical Development, and other technical functions to ensure laboratory investigations are scientifically sound, appropriately documented, completed in a timely manner, and supported by effective root-cause analysis and corrective and preventive actions.
Key ResponsibilitiesOOS, OOT & Laboratory Investigation Leadership
- Oversee QC OOS, OOT, deviations, atypical results, invalid assays, and laboratory investigations across Chemistry, Microbiology, and Raw Materials.
- Lead or facilitate complex, high-impact, recurring, or cross-functional investigations.
- Ensure investigations include clear problem statements, hypotheses, scientifically justified testing, defensible root causes, product-impact assessments, and CAPAs where appropriate.
- Challenge root-cause conclusions not adequately supported by data.
- Facilitate root-cause analysis using 5-Why, fishbone/Ishikawa, fault-tree, and FMEA/risk-based tools, as appropriate.
- Partner with QA to ensure investigations meet internal procedures and applicable cGMP expectations.
- Guide assessment of potential laboratory, method, equipment, sample, analyst, manufacturing, and other assignable causes.
- Support additional testing, retesting, resampling, method troubleshooting, and escalation decisions per approved procedures.
- Ensure laboratory data and scientific evidence support investigation conclusions.
Deviation & CAPA Management
- Provide QC leadership for laboratory deviations and associated CAPAs.
- Ensure corrections, root causes, corrective actions, and preventive actions are clearly distinguished and documented.
- Partner with investigation owners to develop CAPAs addressing systemic causes, not just symptoms.
- Support risk and impact assessments for significant laboratory events.
- Monitor recurring events for additional systemic remediation needs.
- Support CAPA effectiveness evaluations for QC laboratory issues.
- Identify investigation themes and improvement opportunities across procedures, methods, equipment, training, systems, and laboratory controls.
Investigation Trending & Metrics
- Maintain QC investigation metrics covering OOS, OOT, invalid assays, deviations, and CAPAs.
- Trend events across Chemistry, Microbiology, Raw Materials, products, methods, instruments, and testing processes.
Cross-Functional Investigation Support
- Serve as QC's primary technical liaison for investigations involving QA, Manufacturing, Analytical Development, Supply Chain, Product Development, and other functions.
- Partner with Manufacturing to investigate potential manufacturing or process contributors to laboratory findings.
- Communicate laboratory findings, investigation status, risks, and recommended actions to QC and Quality leadership.
- Facilitate multidisciplinary investigation meetings.
- Provide defensible QC data and interpretation for product-impact and quality-risk assessments.
- Support audits, health-authority questions, and inspection activities related to laboratory investigations.
Leadership & Organizational Responsibilities
- Establish consistent investigation standards across QC Chemistry, Microbiology, and Raw Materials.
- Coach analysts, supervisors, managers, and investigation owners in root-cause analysis, technical writing, scientific reasoning, and investigations.
- Improve investigation quality and consistency through training, templates, tools, and standard practices.
- Promote scientific rigor, data integrity, timely escalation, quality ownership, and continuous improvement.
- Influence cross-functional teams to close investigations beyond direct reporting lines.
- Present significant investigation trends, systemic risks, and recommended actions to QC and Quality leadership.
Qualifications- Bachelor's degree in Chemistry, Biochemistry, Biology, Microbiology, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline required.
- Master's degree or advanced scientific degree preferred.
- 10+ years in QC, analytical sciences, pharmaceutical/biotechnology manufacturing, or a related GMP-regulated environment.
- Significant hands-on experience conducting or leading OOS, OOT, deviation, laboratory, and root-cause investigations is required.
- Experience across multiple QC disciplines strongly preferred.
- Strong understanding of cGMP laboratory operations, data integrity, OOS/OOT investigations, deviations, CAPAs, change control, and risk management.
- Knowledge of HPLC/UPLC, GC, spectroscopy, and wet chemistry techniques.
- Working knowledge of microbiological testing and investigations, including bioburden, endotoxin, sterility, and environmental monitoring.
- Strong technical writing; ability to translate complex scientific findings into clear, defensible investigation conclusions.
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Salary Range
$162,000-$175,000 USD
