Senior Manager, QC Analytical Support & Investigations

Ocular Therapeutix•Bedford, MA

About The Position

The Senior Manager, Quality Control – Analytical Support & Investigations is a senior technical leadership role providing investigation oversight and analytical problem-solving support across the Quality Control organization. This individual contributor serves as a central QC resource for OOS, OOT, laboratory deviations, atypical results, invalid assays, and other significant laboratory events associated with QC testing. The role partners 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, timely, and supported by effective root-cause analysis and corrective and preventive actions. The position also establishes consistent investigation standards across QC disciplines, coaches employees and investigation owners, and communicates significant trends, risks, and recommended actions to QC and Quality leadership.

Requirements

Bachelor’s degree in Chemistry, Biochemistry, Biology, Microbiology, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline.
10+ years in QC, analytical sciences, pharmaceutical or biotechnology manufacturing, or a related GMP-regulated environment.
Significant hands-on experience conducting or leading OOS, OOT, deviation, laboratory, and root-cause investigations.
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 skills and ability to translate complex scientific findings into clear, defensible investigation conclusions.

Nice To Haves

Master’s degree or advanced scientific degree.
Experience across multiple QC disciplines.

Responsibilities

Oversee QC OOS, OOT, deviation, atypical-result, invalid-assay, 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 that are not adequately supported by data.
Facilitate root-cause analysis using 5-Why, fishbone/Ishikawa, fault-tree, and FMEA or other 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 under approved procedures.
Ensure laboratory data and scientific evidence support investigation conclusions.
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 and support risk and impact assessments, monitoring of recurring events, and CAPA effectiveness evaluations.
Identify investigation themes and improvement opportunities across procedures, methods, equipment, training, systems, and laboratory controls.
Maintain QC investigation metrics covering OOS, OOT, invalid assays, deviations, and CAPAs; trend events across disciplines, products, methods, instruments, and testing processes.
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 inspections related to laboratory investigations.
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.