Manager, Quality Assurance Compliance

Ocular Therapeutix•Bedford, MA

18h•Onsite

About The Position

Ocular Therapeutix, Inc. 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™. The company 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. Headquartered in Bedford, MA, Ocular Therapeutix strives to build a strong culture where employees can flourish and achieve their career goals, encouraging out of the box thinking, cross-functional collaboration, and creativity.

Requirements

Bachelor’s degree in Pharmaceutical Science, Biomedical Science or a related field.
Six years regulatory experience in the pharmaceutical industry.
Six years working in a GxP commercial and clinical setting.
Six years vendor management, Quality Management System, and compliance.
Six years domestic and international regulatory guidelines such as CFR 210, 211, USP, FDA, ICH, MHRA, or EMA.
Three years electronic systems, such as MasterControl.
Three years external regulatory inspections (e.g., FDA).

Responsibilities

Manage and maintain Supplier Quality Management, Audits, Documentation, Training, Inspection Readiness, and Quality Compliance to drive improvements and achieve adherence with regulatory expectations.
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.
Coordinate vendor audits and manage the qualification of vendors supporting Ocular’s GxP operations, including vendor selection and corresponding risk evaluation.
Collaborate in cross-functional scenarios for the onboarding of vendors, resolution of SCARs (Supplier Corrective Action Requests) and assessment of SCNs (Supplier Change Notifications).
Accomplish the objectives and goals of the Quality Organization.
Manage deviations, change controls, and CAPAs associated with the programs.
Review departmental documentation (e.g., Standard Operating Procedures, Work Instructions, etc.) for gaps and improvements.
Adhere to all the policies and procedures as well as to the GxP guidelines driving the operations at OTX.
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.