Ocular Therapeutix, Inc. · 3 hours ago
Executive Director, Clinical Quality Assurance
Bedford, MA
Full-time
Hybrid
Director/Executive
$259K/yr - $276K/yr
15+ years expOcular Therapeutix, Inc. is a biopharmaceutical company focused on innovative therapies for eye diseases. The Executive Director of Clinical Quality Assurance is responsible for overseeing all aspects of Quality Assurance, ensuring compliance with Good Clinical Practices and regulatory standards, while leading a high-performing team within the Clinical Quality Assurance group.
BiotechnologyHealth CareMedical Device
Responsibilities
Assurance strategies, ensuring alignment of the Organization's goals and regulatory requirements. Set quality objectives and create strategic action plans to achieve desired results
Provide visionary leadership and strategic direction to the CQA Team
Responsible for shaping the Quality Culture across the Clinical Organization, ensuring compliance with regulatory standards, and driving continuous improvement in quality systems and processes
Develop and execute a comprehensive quality strategy aligned with Ocular's business objectives and regulatory requirements for ophthalmic combination drug products
Lead, mentor, and develop a high-performing CQA Team, fostering a culture of excellence, innovation, and continuous improvement
Collaborate with cross-functional leadership to integrate quality considerations into all aspects of clinical development
Serve as the primary liaison with regulatory agencies on CQA matters, representing Ocular in inspections and audits
Establish Key Performance Indicators (KPIs) to measure and enhance the effectiveness of quality systems and operations performance
Oversee the development and implementation of quality policies, procedures, and training programs to ensure GCP compliance
Provide executive-level guidance on quality risk management, and CAPA (Corrective/Preventive Actions)
Manage CQA budget, resource allocation, and strategic hiring decisions
Participate in due diligence activities for potential partnerships, acquisitions, or expansion opportunities, assessing quality implications and integration
Stay informed on industry standards and governmental regulations to ensure all Clinical Quality processes meet or exceed these requirements
Lead CQA investigations as needed for all products in development. Accountable for the timely completion of CAPAs to ensure GCP compliance. Maintain the clinical and vendor audit program to monitor performance and compliance
Develop and implement training programs, standards, tools, and methods to promote quality culture throughout the Clinical Organization. Ensure that all team members are adequately trained in applicable procedures. Oversee development of personnel within CQA. Support employee development plans and provide regular performance feedback
Drive continuous improvement initiatives across all quality processes. Utilize data and analytics to identify areas for enhancement and implement solutions
Serve as the primary point of contact for Clinical Quality- related inquiries. Provide timely and regular reports to Senior Management on compliance issues, status of CQA programs, CI initiatives, and QMS operational status
Qualification
Required
Bachelor's degree in scientific discipline or related field required or advance-degree
15+ years of GCP CQA in the pharmaceutical industry with cross-functional experience
5+ years of experience in a senior leadership role such as Sr. Director or higher
Experience in QMS and compliance systems
Experience supporting operational activities both strategically and tactically
Knowledge of domestic and international regulatory guidelines such as, CFR 210, 211, 820, USP, FDA, ICH, MHRA, EMA, and others
Experience with external regulatory inspections (e.g., FDA)
Excellent organizational skills and attention to detail
Strong interpersonal, verbal and written communication skills
Strong cross-functional communication skills
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
Steve Meyers
Senior Vice President, Commercial
Recent News
2025-12-09
2025-12-08
Company data provided by crunchbase