About the job
Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a pioneering biopharmaceutical company dedicated to the formulation, development, and commercialization of cutting-edge therapies for eye diseases and conditions. Utilizing our proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™, we have established a robust pipeline of innovative drug delivery solutions aimed at simplifying and enhancing the current standards of care. As we strive to become a leader in the ophthalmic industry, we foster a dynamic workplace culture at our headquarters in Bedford, MA, where creativity, cross-functional collaboration, and out-of-the-box thinking are highly valued.
Principal Duties and Responsibilities include the following:
- Oversee and enhance key areas including Supplier Quality Management, Audits, Documentation, Training, Inspection Readiness, and Quality Compliance to ensure alignment with regulatory expectations.
- Prepare the site for successful internal and external audits, ensuring that all processes and systems comply with applicable regulatory guidelines.
- Lead the coordination of vendor audits and manage the qualification of vendors supporting Ocular’s GxP operations, focusing on vendor selection and risk evaluation.
- Facilitate cross-functional collaboration for vendor onboarding, resolution of Supplier Corrective Action Requests (SCARs), and assessment of Supplier Change Notifications (SCNs).
- Achieve the objectives of the Quality Organization by managing deviations, change controls, and Corrective and Preventive Actions (CAPAs).
- Evaluate departmental documentation (e.g., Standard Operating Procedures, Work Instructions) for gaps and opportunities for improvement.
- Ensure adherence to all policies and procedures as well as GxP guidelines, identifying areas for enhancement to optimize processes and add efficiency within Quality operations.
- Participate in the implementation of new electronic systems like MasterControl.

