I.       Position Summary:

Responsible for maintaining quality standards for Ocular’s pharmaceutical and medical device products by managing activities associated with Supplier Quality Management, Document Control, Training, Internal Auditing, and Inspection Readiness. This is a critical position, and onsite presence is essential due to the level of cross-functional collaboration that it involves. This position is reporting to the Sr. Director of Quality Systems and Compliance.

II.    Principal Duties and Responsibilities include the following:

• Manage and maintain the following areas to drive improvements and achieve adherence with regulatory expectations: Supplier Quality Management, Audits, Documentation, Training, Inspection Readiness, and Quality Compliance.
• 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 under responsibility, as
• 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.
• Perform additional duties as deemed appropriate.

III. Qualification Requirements:

• Bachelor’s
• 10+ years of experience in the pharmaceutical industry.
• Experience working in a GxP setting (commercial and clinical).
• Expertise in vendors management, QMS, and compliance.
• Knowledge of domestic and international regulatory guidelines such as, CFR 210, 211, USP, FDA, ICH, MHRA, EMA, and others.
• Knowledge of electronic systems, such as MasterControl.
• Experience with external regulatory inspections (e.g., FDA).
• Excellent organizational skills and attention to
• Strong interpersonal, verbal and written communication
• Computer literacy, proficiency in MS Office, Excel, PowerPoint,