Ocular Therapeutix, Inc. · 3 hours ago
Manager, Quality Compliance
Bedford, MA
Full-time
Onsite
Senior Level, Lead/Staff
$166K/yr - $185K/yr
10+ years expOcular Therapeutix, Inc. is a biopharmaceutical company focused on innovative therapies for eye diseases. The Manager of Quality Compliance is responsible for maintaining quality standards for pharmaceutical and medical device products, managing risk management, supplier quality, and ensuring compliance with regulatory guidelines.
BiotechnologyHealth CareMedical Device
Responsibilities
Manage and maintain the following areas to drive improvements and achieve adherence with regulatory expectations: Risk Management, Supplier Quality Management, Audits, Documentation, Training, Inspection Readiness, and Quality Compliance
Inspection Readiness: Prepare the site for the success of internal and external audits ensuring that all the processes and systems remain aligned and in compliance with the applicable regulatory guidelines and industry standards. Execute internal audits as necessary
Supplier Qualification: Manage the qualification of vendors supporting Ocular’s GxP operations, including coordinating and executing supplier qualification audits. Collaborate in cross-functional scenarios for the onboarding of suppliers, resolution of SCARs (Supplier Corrective Action Requests) and assessment of SCNs (Supplier Change Notifications)
Risk Management: Identify, assess, and mitigate risks related to Ocular drug development, manufacturing, safety, regulatory compliance, and market access, focusing on ICH Q9 and using tools like FMEA to ensure patient safety, regulatory adherence, and business continuity
Training: Manage logistics for mandatory training (GMP, SOPs, skills) using Ocular’s LMS, ensuring regulatory compliance by scheduling sessions, tracking records, generating reports, supporting audits, and coordinating with Quality/Dept heads to align training with production needs and quality standards
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
Participate in the implementation of new electronic systems, such as MasterControl, as necessary
Adhere to all the policies and procedures as well as to the GxP guidelines driving the operations at OTX
Accomplish the objectives and goals of the Quality Organization
Perform additional duties as deemed appropriate
Qualification
Required
Bachelor's
10+ years of experience in the pharmaceutical industry
Experience working in a GxP setting (commercial and clinical)
Expertise in Risk Management, Inspection Readiness, Supplier Management, Training, and general Quality Compliance
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
2025-12-09
2025-12-08
Company data provided by crunchbase