Associate Director, Clinical Quality Assurance

The Quality team at EyePoint ensures that the highest standards of product quality, safety, and regulatory compliance are upheld across all initiatives. This team implements rigorous quality systems and continuous improvement practices to safeguardproduct integrity and support patient-focused innovation for serious retinal diseases.

The Associate Director of Clinical Quality Assurance will provide quality oversight of clinical development programs and help develop, manage, and improve existing quality systems to ensure compliance with GCP for EyePoint’s internal and external activities. This includes the expansion of the existing Quality Management System (QMS), development of documents, training of personnel, and the quality oversight of clinical trials. This position will support the Bioresearch Monitoring (BIMO) inspection readiness initiatives, as well as provide QA support of post approval pharmacovigilance systems.

This position will work directly with Clinical Operations, Clinical Development, Biometrics and Pharmacovigilance teams to provide continual oversight and foster continued GCP compliance.

This position is remote and will report to the Director, Clinical Quality Assurance. This position does not currently have any direct reports but potentially will manage junior CQA or consultant staff as the team grows.

• Collaborate with Leadership to lead, implement, and continuously improve the QMS by establishing quality goals and initiatives, and ensuring compliance to applicable global regulations and standards, such as FDA and ICH.
• Drive the clinical quality and compliance vision and mindset of the entire company in close collaboration with Leadership
• Help to define clear CQA objectives and ensure progress and cross-functional completion of responsibilities
• Identify and assess compliance risks, and develop and implement risk mitigation strategies
• Plan, lead, and oversee the study specific audit programs, including audits of clinical investigator sites, clinical documents (e.g. CSR), and clinical systems/software and databases
• Oversee all aspects of Quality related to execution of clinical studies, including document review and providing guidance, interpretation, and information on regulations, guidelines, and standards to the study teams
• Monitor and track quality metrics to identify trends and areas of improvement
• Drive initiatives related to quality process improvement
• Represent CQA at internal meetings and provide input from a CQA perspective
• Lead and/or assist with FDA/Health Authority inspections of EyePoint or clinical sites
• Lead or participate in conducting risk assessments and implementation of proactive measures to prevent and address quality issues, deviations, and non-conformances within the GCP context.
• Oversee processes to ensure standard procedures are updated to reflect current regulations, technological changes, trends, and best practices.
• Participate in the selection, evaluation, and auditing of vendors, ensuring that they meet quality standards and regulatory requirements
• Provide routine communication to Leadership about the overall status of the Quality Management System as it pertains to clinical programs.
• Keeps current with GCP quality and regulatory surveillance, as well as trends, and shares information with applicable personnel.

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

• Extensive knowledge of ICH Guidelines and international regulatory requirements for the conduct of clinical development programs
• Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
• Experience interacting and/or leading regulatory health authorities at pre- and post-approval
• Demonstrated ability to build rapport with team members and partners
• Excellent organization skills, attention to detail and ability to handle multiple competing and changing priorities within tight timelines
• Strong analytical skills with practical knowledge for identifying key risk indicators and quality tolerance limits, with the ability to evaluate Quality Systems and drive value added enhancements
• Strong team player that has a customer service approach and is solution oriented
• Able to proactively anticipate needs and follow through on all assigned tasks
• Extensive experience auditing vendors, clinical trial documents, and clinical investigator sites

Bachelors or Advanced degree in scientific discipline.

• Minimum of 10 years related experience within the pharmaceutical or biotech industry
• Minimum of 8 years related GCP QA experience at a CRO, biotech, or pharma company

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