Associate Director, Clinical Quality Assurance

EyePoint’s Quality team upholds the highest standards of product quality, safety, and regulatory compliance across all initiatives. This role implements rigorous quality systems and continuous improvement practices to safeguard product integrity and support patient-focused innovation for serious retinal diseases.

About the role

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 Good Clinical Practice (GCP) for EyePoint’s internal and external activities. Responsibilities include expanding the existing Quality Management System (QMS), developing documents, training personnel, and overseeing clinical trials. This position supports Bioresearch Monitoring (BIMO) inspection readiness and provides QA support for post-approval pharmacovigilance systems. The role is remote and reports to the Director of Clinical Quality Assurance, with potential future management of junior CQA or consultant staff as the team grows.

Responsibilities

• Collaborate with Leadership to lead, implement, and continuously improve the QMS by establishing quality goals and initiatives, ensuring compliance with applicable global regulations and standards (e.g., FDA, ICH).
• Drive the clinical quality and compliance vision and mindset of the company in close collaboration with Leadership.
• 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 study-specific audit programs, including audits of clinical investigator sites, clinical documents (e.g., Clinical Study Reports), and clinical systems/software/databases.
• Oversee all aspects of Quality related to the execution of clinical studies, including document review and providing guidance on regulations, guidelines, and standards to study teams.
• Monitor and track quality metrics to identify trends and areas for improvement.
• Drive initiatives related to quality process improvement.
• Represent Clinical Quality Assurance (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.
• Conduct risk assessments and implement 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 to ensure they meet quality standards and regulatory requirements.
• Provide routine communication to Leadership about the overall status of the QMS as it pertains to clinical programs.
• Stay current with GCP quality and regulatory surveillance, as well as trends, and share information with applicable personnel.

Requirements

• Bachelor’s or advanced degree in a scientific discipline.
• Minimum of 10 years of related experience within the pharmaceutical or biotech industry.
• Minimum of 8 years of related GCP QA experience at a CRO, biotech, or pharma company.
• Travel up to 20% to facilitate partnerships and execution of duties.

Skills

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

Pay

Salary Range: $154,500 USD – $195,700 USD.

Benefits

• Transformational Innovation: Commitment to changing patients’ lives through sight, embracing challenges with curiosity, and continuously improving products and processes.
• Unwavering Integrity: High ethical standards and responsible leadership at every level to serve patients, employees, and the community.
• Compassionate Excellence: A culture where fun and excellence coexist, emphasizing enjoyment of work and care for one another alongside exceptional outcomes.
• Inclusive Collaboration: Valuing diverse perspectives and ensuring everyone feels respected and encouraged to contribute ideas.