New · posted Nov 7
Ocular Therapeutix · Pharmaceuticals
Senior Manager, QC Analytical Support & Investigations
- Bedford, MA
- On-site
- Full-time
- Manager
The role
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.
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.
What you need
- 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.
What you'll do
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 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.
Pay
$162,000 – $175,000 a year
Employer provided$162,000—$175,000 USD
Where you'll work
Bedford, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Bedford, MAEqual opportunity, accessibility and legal noticesOcular Therapeutix's statements, word for word
Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/. For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.
Job intelligence
The context around this role
Live data · November 7, 2026
Salary intelligence
How the pay compares
This role's midpoint is 47% above the US median for Quality Control roles at this level.
This roleEmployer provided
Manager roles in the US30 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $162,000 | — | $175,000 |
| All US (middle half) | $104,000 | $114,250 | $138,375 |
This role: Ocular Therapeutix's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, November 7, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 248 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Ocular Therapeutix's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 47 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Investigations and CAPA31
- Lab testing and methods25
- Collaboration and leadership14
- Documentation and SOPs7
- GMP and compliance4
- Quality systems and risk3
- Data and digital systems2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Control work in pharmaceuticals, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical ProductionNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- ICHICH Q1 stability testing(official source, opens in a new tab)Stability testing of drug substances and drug products
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- ICHICH Q3 impurities(official source, opens in a new tab)Impurities in drug substances and products, residual solvents and elemental impurities
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratories
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
Company hiring pulse
Ocular Therapeutix on Regulatory Jobs
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- Open roles
- 2
- Distinct roles
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Senior Manager, QC Analytical Support & Investigations at Ocular Therapeutix
Open until filled. $162K–$175K a year, employer provided.