Job description
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.
Position Summary:
The Executive Director of Clinical Quality Assurance (CQA) is accountable for overseeing all aspects of Quality Assurance within the CQA Team as part of the overall Quality Organization at Ocular. This role involves the planning, development, and execution of QA policies, programs, and initiatives to ensure that all Good Clinical Practices (GCPs) related activities meet the necessary quality standards while this role is also accountable for company compliance with all GCP and governmental regulations.
The Executive Director will set quality objectives, formulate strategic action plans, establish audit protocols and be accountable for overseeing the Quality Management System governing GCP operations. The Executive Director will provide leadership and guidance to personnel within the CQA group and direct support to other critical Functional Areas such as Clinical Operations and Clinical Development.
This is a strategic role that is critical to maintain the continuity of Ocular’s clinical studies to guarantee patient’s safety and confidentiality and ensure the success of each clinical study by keeping them in compliance with the corresponding regulations. This role is reporting to the VP Global Quality, and it is expected to be either onsite (preferrable) or remote.
Principal Duties and Responsibilities include the following:
- 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
- Regulatory Compliance: Stay informed on industry standards and governmental regulations to ensure all Clinical Quality processes meet or exceed these requirements.
- Audit & Surveillance: 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.
- Training & Development: 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.
- Continuous Improvement (CI): Drive continuous improvement initiatives across all quality processes. Utilize data and analytics to identify areas for enhancement and implement solutions.
- Reporting & Communication: 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 Requirements:
- 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
- Strong interpersonal, verbal and written communication
- Strong cross-functional communication skills
Supervisory Responsibilities:
- Responsible for supervising the following levels within CQA: Director/Senior Director
Working Conditions:
- Remote or Office based
- Travel may be required (~25% or less)
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.
