Ocular Therapeutix, Inc. · 12 hours ago
Manager, Risk Management
Bedford, MA
Full-time
Hybrid
Mid, Senior Level
$125K/yr - $175K/yr
6+ years expOcular Therapeutix, Inc. is a biopharmaceutical company focused on innovative therapies for eye diseases. The Quality Risk Management (QRM) Manager is responsible for driving the QRM program, ensuring compliance with quality regulations, and fostering a risk-based culture to ensure patient safety and product quality throughout the product lifecycle.
BiotechnologyHealth CareMedical Device
Responsibilities
Lead the development and execution of the site/corporate QRM program, ensuring alignment with global policies, procedures, and regulatory standards (FDA/EMA/ICH)
Facilitate formal risk assessments (e.g., FMEA, HAZOP, PHA) with cross-functional teams (Manufacturing, R&D, Supply Chain) to identify and mitigate risks to product quality, safety, and compliance
Maintain the corporate/site risk register and oversee the tracking of risk mitigation actions to closure
Act as the Subject Matter Expert (SME) for QRM during internal audits, third-party audits, and Health Authority inspections
Embed QRM principles into Quality Systems, including Change Control, Deviations, CAPA, and Material Qualification
Develop and deliver QRM training to cross-functional stakeholders to enhance risk awareness and the consistent application of QRM tools
Define, monitor, and report on key quality risk metrics (KPIs) to leadership, identifying trends to drive continuous improvement
Manage deviations, change controls, and CAPAs associated with the programs under responsibility, as
Review departmental documentation (e.g., Standard Operating Procedures, Work Instructions, etc.) for gaps and improvements, and revise as necessary
Identify opportunities for improvement and implement necessary actions to optimize the processes/systems and add efficiency to the Quality operations
Adhere to all the policies and procedures as well as to the GxP guidelines driving the operations at Ocular Therapeutix
Accomplish the objectives and goals of the Quality Organization as appropriate
Perform additional duties as deemed appropriate
Qualification
Required
6+ years of experience in the pharmaceutical or biotechnology industry, with at least 2–4 years specifically focusing on Quality Assurance, Quality Systems, or Quality Risk Management
Deep knowledge of GxP regulations (cGMP, GCP, GLP), ICH Q9(R1), and ISO standards
Proven experience with QRM tools and methodologies (e.g., FMEA, Fault Tree Analysis, HACCP)
Strong leadership and influencing skills to work in a matrixed organization without direct authority
Excellent communication and facilitation skills for leading cross-functional teams
Ability to manage ambiguity and prioritize multiple projects under tight deadlines
Bachelor's degree
Knowledge of domestic and international regulatory guidelines such as, CFR 210, 211, USP, FDA, ICH, MHRA, EMA, and others
Knowledge of electronic systems, such as MasterControl
Experience with external regulatory inspections (e.g., FDA)
Excellent organizational skills and attention to detail
Strong interpersonal, verbal and written communication skills
Computer literacy, proficiency in MS Office, Excel, PowerPoint
Company
Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company committed to redefining the retina experience across drug development, treatment, and outcomes.
51-200 employees
H1B Sponsorship
Ocular Therapeutix, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (1)
2023 (3)
2022 (4)
2021 (10)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$1.19BKey Investors
Ascension VenturesPolaris Partners
2025-09-30Post Ipo Equity· $475M
2024-02-22Post Ipo Equity· $325M
2023-12-13Post Ipo Equity· $115.11M
Leadership Team
Michael Goldstein
Chief Strategy Advisor
Steve Meyers
Chief Commercial Officer
Recent News
2026-01-23
2026-01-22
2026-01-22
Company data provided by crunchbase