Ocular Therapeutix, Inc. · 18 hours ago
Senior Manager, Clinical Quality Assurance
United States
Full-time
Remote
Senior Level, Lead/Staff
$170K/yr - $185K/yr
8+ years expOcular Therapeutix, Inc. is a biopharmaceutical company focused on innovative therapies for eye diseases. The Senior Manager, Clinical Quality Assurance will provide strategic input to GCP-related compliance activities, manage audits, and oversee quality assurance for clinical trials to ensure compliance and quality excellence.
BiotechnologyHealth CareMedical Device
Responsibilities
Plan and conduct audits of suppliers, investigator sites, and internal processes to assess compliance with the applicable regulatory requirements, guidelines, standards, agreements and / or Standard Operating Procedures
Write and distribute audit reports
Collaborate with cross-functional teams to ensure timely resolution of audit findings and follow up on corrective and preventive actions (CAPAs)
Manage audit scheduling, reporting, and tracking of audit activities, including audits outsourced to third parties
Evaluate the design, feasibility, and operational integrity of clinical trial protocols
Identify gaps or weaknesses in protocol implementation that could impact trial participant safety, data reliability, or regulatory compliance
Ensure consistent implementation, use and review of SOPs
Escalate issues to management in a timely manner implementing appropriate solutions, including preventive actions
Collaborate with internal cross-functional teams to improve quality and increase efficiencies
Support Ocular Therapeutix Quality Management System (QMS) by assisting with the development and updating of standard operating procedures and other controlled documents
Lead functional process improvement initiatives to drive efficiencies and effectiveness of Clinical Quality Assurance processes
Provide guidance and training on GXP regulations, corporate standards, and quality policies
Provide support for inspection readiness and inspections
All other duties as needed or assigned
Qualification
Required
A minimum of a bachelor's degree in Life Sciences or equivalent
Experience may be substituted for education
8+ years of experience in the pharmaceutical / biopharmaceutical / CRO industry (experience in GXP roles)
Strong GCP auditing experience
Strong understanding of ICH-GCP, FDA regulations and guidance, as well as international requirements and standards
Excellent analytical, communication and problem-solving skills
Ability to manage multiple simultaneous projects
Well-organized, meticulous and thorough
Commitment to diversity, equity, and inclusion
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
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
2026-01-22
2026-01-22
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