Director of Quality Systems & GMP Compliance

Position Summary:

Maintaining and continually developing the Ocular Therapeutix quality management system to ensure all stages throughout the product lifecycle (development through discontinuation) are conducted in compliance with global GMPs applicable to the stage and to ensure the company is GMP inspection ready at all times.

Principal Duties and Responsibilities include the following:

• Management, leadership and development of the Document Control team. 
• Maintain and develop the company quality management system to ensure at all times that it meets with global GMP guidelines with respect to medicinal and medical device products. 
• Ensuring the quality management system is phase appropriate to each stage of the product lifecycle.
• Collaborate with other departments involved in GMP activities to ensure they are commensurate with current GMPs and best practices.
• Ensuring the company is GMP inspection ready to enable the company to maintain its licenses and certificates in order to execute its current and future development programs and commercialize its products.
• Management of the internal audit program.
• Oversee the facilities’ Document Control & Labeling programs.
• In collaboration with Training department, develop, conduct and continually improve the GMP trainings provided. 
• Responsible for the management of any recalls and returns.
• Responsible for the assessment of product in the event of temperature excursions during shipping.
• Participate in Risk Management activities and approval as required.
• Contribute to Management reviews, quality meetings and the annual product reviews.
• Contribute to the development, monitoring and reporting on GMP metrics.
• Perform quality data integrity reviews to ensure data is reliable in support of regulatory dossiers.
• Maintain current knowledge on FDA and European regulations, directive and guidelines relevant to GxP and determine its impact on company studies.
• Provide timely and informative reports to senior leadership and management on product quality status, quality improvement initiatives, and quality management system operational status.
• Oversee development of personnel within the department; direct training programs and prepare employee development plans.
• Contribute to the Quality budgeting process.
• Delegate for Head of Quality in role as audit host in regulatory and customer inspections.
• Deputize for the Head of Quality when applicable.
• Perform other duties as assigned

Qualification Requirements:

• Bachelor’s degree in Life Sciences.
• At least 7 years working in a pharmaceutical and/or device industry within Quality Assurance.
• Excellent knowledge of US cGMPs and a good understanding of global GMPs. 
• Experience hosting regulatory inspections.
• Experience in the application and knowledge of phase appropriate quality. 
• Strong interpersonal, negotiation, presentation and communication skills.