Associate Director, Clinical Quality Assurance
EyePoint
August 12, 2026
Remote
United States
Clinical Research and Development
Associate Director of Clinical Quality Assurance
Primary responsibilities:
- Lead, implement, and continuously improve the Clinical Quality Assurance (CQA) Quality Management System (QMS) by setting quality goals/initiatives and ensuring compliance with global regulations and standards (e.g., FDA, ICH).
- Define CQA objectives and ensure cross-functional completion.
- Identify and assess compliance risks; develop and implement risk mitigation strategies.
- Plan, lead, and oversee study-specific audit programs (sites, clinical documents such as CSRs, clinical systems/software, and databases).
- Oversee quality for execution of clinical studies, including document review and regulatory guidance to study teams.
- Monitor and track quality metrics; drive quality process improvement initiatives.
- Represent CQA in internal meetings and provide CQA input.
- Lead and/or support FDA/Health Authority inspections (EyePoint and/or clinical sites).
- Conduct GCP-context risk assessments; address deviations/non-conformances.
- Ensure SOP updates reflect current regulations, technological changes, trends, and best practices.
- Select, evaluate, and audit vendors for quality and regulatory compliance.
- Provide routine updates to leadership on QMS status.
Other requirements:
- Remote; travel up to 20% (depending on growth/location).
Qualifications/skills required:
- Extensive knowledge of ICH guidelines and international clinical regulatory requirements.
- Demonstrated ability to manage competing priorities; excellent organization and attention to detail.
- Experience engaging with regulatory health authorities pre- and post-approval.
- Strong analytical skills for risk indicators and quality tolerance limits; ability to enhance Quality Systems.
- Strong team player; customer-service mindset; solution-oriented.
- Proactive, follow-through on assigned tasks.
- Extensive experience auditing vendors, clinical trial documents, and investigator sites.
Education: Bachelor’s or advanced degree in a scientific discipline.
Experience:
- Minimum 10 years in pharmaceutical/biotech industry.
- Minimum 8 years GCP QA experience (CRO/biotech/pharma).
Compensation: Salary range $154,500 USD – $195,700 USD.
Primary responsibilities:
- Lead, implement, and continuously improve the Clinical Quality Assurance (CQA) Quality Management System (QMS) by setting quality goals/initiatives and ensuring compliance with global regulations and standards (e.g., FDA, ICH).
- Define CQA objectives and ensure cross-functional completion.
- Identify and assess compliance risks; develop and implement risk mitigation strategies.
- Plan, lead, and oversee study-specific audit programs (sites, clinical documents such as CSRs, clinical systems/software, and databases).
- Oversee quality for execution of clinical studies, including document review and regulatory guidance to study teams.
- Monitor and track quality metrics; drive quality process improvement initiatives.
- Represent CQA in internal meetings and provide CQA input.
- Lead and/or support FDA/Health Authority inspections (EyePoint and/or clinical sites).
- Conduct GCP-context risk assessments; address deviations/non-conformances.
- Ensure SOP updates reflect current regulations, technological changes, trends, and best practices.
- Select, evaluate, and audit vendors for quality and regulatory compliance.
- Provide routine updates to leadership on QMS status.
Other requirements:
- Remote; travel up to 20% (depending on growth/location).
Qualifications/skills required:
- Extensive knowledge of ICH guidelines and international clinical regulatory requirements.
- Demonstrated ability to manage competing priorities; excellent organization and attention to detail.
- Experience engaging with regulatory health authorities pre- and post-approval.
- Strong analytical skills for risk indicators and quality tolerance limits; ability to enhance Quality Systems.
- Strong team player; customer-service mindset; solution-oriented.
- Proactive, follow-through on assigned tasks.
- Extensive experience auditing vendors, clinical trial documents, and investigator sites.
Education: Bachelor’s or advanced degree in a scientific discipline.
Experience:
- Minimum 10 years in pharmaceutical/biotech industry.
- Minimum 8 years GCP QA experience (CRO/biotech/pharma).
Compensation: Salary range $154,500 USD – $195,700 USD.