Associate Director, Clinical Quality Assurance

EyePoint’s Quality team ensures 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 GCP for EyePoint’s internal and external activities. Responsibilities include expanding the Quality Management System (QMS), developing documents, training personnel, and overseeing clinical trials. This position supports Bioresearch Monitoring (BIMO) inspection readiness and post-approval pharmacovigilance systems, working directly with Clinical Operations, Clinical Development, Biometrics, and Pharmacovigilance teams to foster GCP compliance. This is a remote role reporting to the Director of Clinical Quality Assurance, with potential to manage 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 global regulations (e.g., FDA, ICH).
• Drive the clinical quality and compliance vision in collaboration with Leadership.
• Define clear CQA objectives and ensure cross-functional completion of responsibilities.
• Identify and assess compliance risks, developing and implementing risk mitigation strategies.
• Plan, lead, and oversee study-specific audit programs, including audits of clinical investigator sites, clinical documents (e.g., CSR), and clinical systems/software.
• Oversee all Quality aspects of clinical study execution, including document review and providing regulatory guidance to study teams.
• Monitor and track quality metrics to identify trends and areas for improvement.
• Drive quality process improvement initiatives.
• 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.
• Conduct risk assessments and implement proactive measures to address quality issues, deviations, and non-conformances within the GCP context.
• Ensure standard procedures are updated to reflect current regulations, technological changes, and best practices.
• Participate in the selection, evaluation, and auditing of vendors to ensure they meet quality and regulatory standards.
• Provide routine communication to Leadership about the status of the QMS as it pertains to clinical programs.
• Stay current with GCP quality and regulatory trends, sharing insights with applicable personnel.

Requirements

• 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 priorities within tight timelines.
• Strong analytical skills for identifying key risk indicators and quality tolerance limits, with the ability to evaluate and enhance Quality Systems.
• Customer-service approach with a solution-oriented mindset.
• Proactive in anticipating needs and following through on assigned tasks.
• Extensive experience auditing vendors, clinical trial documents, and clinical investigator sites.

Qualifications

• 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 GCP QA experience at a CRO, biotech, or pharma company.

Travel

Up to 20% travel may be required to facilitate partnerships and execute duties.

Pay

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

Benefits

• Transformational Innovation: Forward-looking culture that embraces challenges, continuous learning, and problem-solving to push the limits of science and technology.
• Unwavering Integrity: High ethical standards and responsible leadership at every level, valuing trust from 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: Commitment to seeing through others’ perspectives, working as one team, and ensuring everyone feels valued, respected, and encouraged to contribute.