Director, Clinical Quality Assurance

Role Summary

Director, Clinical Quality Assurance. Remote position reporting to the Senior Director, Global Quality Assurance. Responsible for leading clinical quality assurance efforts to ensure GCP compliance for in-house and external activities.

Responsibilities

• Manage a team of clinical quality assurance professionals; develop, manage, and improve quality systems to ensure GCP compliance for EyePoint activities.
• Expand the Clinical Quality Management System (QMS); develop documents; train personnel; provide quality oversight of clinical development.
• Lead BioResearch Monitoring Program (BIMO) inspection readiness; provide QA support for post-approval pharmacovigilance systems.
• Collaborate with EyePoint Clinical Operations, Development, Biometrics, and Pharmacovigilance leadership to foster GCP compliance.
• Lead, implement, and improve the QMS; establish quality goals and ensure compliance with FDA, ICH, and global regulations.
• Drive the clinical quality and compliance vision across the company; define CQA objectives and drive cross-functional progress; lead risk analysis and mitigation.
• May conduct audits of CROs, vendors, clinical sites, systems, and databases.
• Oversee quality related to execution of clinical studies; monitor quality metrics and drive process improvements.
• Represent GCP QA at internal meetings and provide CQA input; lead or assist with FDA/Health Authority inspections.
• Provide leadership and direction to staff consistent with GCP; conduct risk assessments; implement preventive measures for quality issues, deviations, and non-conformances.
• Ensure standard procedures are updated to reflect current regulations and best practices; participate in vendor selection/evaluation.
• Communicate regularly to Senior Leadership on QMS status; stay current with GCP regulatory surveillance and trends.

Qualifications

• Extensive knowledge of ICH Guidelines and GCP, including international regulatory requirements for clinical development.
• Ability to manage multiple priorities and allocate resources effectively.
• Experience interacting with or leading regulatory health authorities at pre- and post-approval inspections.
• Proven ability to build rapport with team members and partners.
• Strong organizational skills and attention to detail; capable of handling changing priorities within tight timelines.
• Ability to evaluate Quality Systems and drive value-added enhancements.
• Customer-service oriented, collaborative team player; solution-focused.
• Proactive with the ability to anticipate needs and follow through on tasks.

Education

• Bachelors or Advanced degree in a scientific discipline.

Experience

• Minimum of 15 years of industry experience.
• Minimum of 10 years of GCP QA experience at a CRO, biotech, or pharma company.
• 3+ years of GCP QA leadership experience, with a track record managing CROs and leading sponsor CQA duties.

Additional Requirements

• Travel will be required to facilitate partnerships and execution; up to 20% travel may be necessary depending on organizational growth and location.