Sr. Manager/Associate Director, Clinical Quality Assurance

Role Summary

Sr. Manager/Associate Director, Clinical Quality Assurance. This remote role reports to the Director, Clinical Quality Assurance.

Responsibilities

• Represent and promote clinical quality and compliance vision and mindset for the entire company.
• Help to define clear CQA objectives and ensure progress and cross-functional completion of responsibilities; use judgment to develop solutions, and drive risk analysis and mitigation strategies.
• Provide Quality Assurance oversight, compliance support and be the QA representative for EyePoint Clinical Program/Study Teams.
• Conduct audits of CROs and vendors, clinical sites, and clinical systems/software and databases.
• Follow-up with vendors to ensure any audit observations are closed appropriately.
• Conduct internal audits and follow-up for closing investigations and audit observations.
• Lead clinical affairs in sponsor deviation and investigation process.
• Ensure that sponsor deviations are analyzed for corrective and preventive actions (CAPAs).
• Oversee all aspects of Quality related to execution of assigned clinical studies.
• Prepare for FDA/Health Authority inspections of EyePoint or clinical sites.
• Provide leadership, guidance, and direction to staff consistent with GCP.
• Participate in initiatives related to critical quality processes such as essential document management, eTMF, data management, trial management, investigational product management, etc.
• Ensure standard procedures are updated to reflect current regulations, technological changes, trends, and best practices.
• Ensures adherence to GCP requirements and SOPs including training plans and executed training.
• Takes lead role in organizing and completing investigations, coordinates with other departments involved, and drives closure in a timely manner.
• Provide routine communication to the Leadership Team about the overall status of the Quality Management System.
• Performs other duties as assigned.

Qualifications

• Excellent verbal and written communication skills, detail-oriented personality, and ability to work and drive change across functions.
• Experience interacting with regulatory health authorities at pre- and post-approval inspection.
• Established expertise and training in GCP systems.
• Experience with FDA, ICH and EMEA guidelines and regulations.
• Ability to evaluate Quality Systems and drive value added enhancements.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and suppliers.

Education

• Bachelors or Advanced degree in a scientific discipline.

Experience

• 5+ years of previous related GCP QA experience
• 10+ years working in a CRO, biotech, or pharma industry

Additional Requirements

• Travel will be required to facilitate robust partnerships and execution.
• Depending on growth of organization and the primary work location, travel is estimated to be up to 20%