Senior Manager, QC Analytical Support & Investigations

Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space. Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity. Position Summary The 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 Responsibilities OOS, 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 te