Associate Director, Clinical Quality Assurance

BioSpace; United States; Remote; USD 155,000 - 196,000; Full time

Job summary

EyePoint Pharmaceuticals seeks an Associate Director of Clinical Quality Assurance to oversee GCP compliance across clinical programs, expand the QMS, and provide QA support for trials. You will partner with Clinical Operations, Development, Biometrics and Pharmacovigilance to safeguard data integrity and patient safety.

This remote US role requires a Bachelor’s or higher in science, 10+ years in pharma/biotech QA, and proven experience with regulatory authorities and vendor audits.

Qualifications

• Extensive knowledge of ICH Guidelines and international regulatory requirements for clinical development.
• Ability to handle multiple competing priorities and utilize resources effectively.
• Experience interacting with regulatory health authorities at pre- and post- approval.
• Ability to build rapport with team members and partners.
• Excellent organization skills, attention to detail, and ability to handle changing priorities.
• Strong analytical skills to identify risk indicators and assess quality systems.
• Strong team player with customer-service mindset and solution orientation.
• Ability to anticipate needs and follow through on tasks.
• Extensive experience auditing vendors, clinical trial documents, and investigator sites.

Responsibilities

• Lead, implement, and improve the QMS and establish quality goals in compliance with FDA and ICH.
• Drive the clinical quality and compliance vision with Leadership.
• Define CQA objectives and ensure cross-functional progress.
• Identify and mitigate compliance risks with proactive strategies.
• Plan and oversee study-specific audit programs (sites, documents, systems).
• Oversee quality aspects of clinical studies, provide guidance on regulations and standards.
• Monitor quality metrics and identify trends for improvement.
• Lead or support FDA/Health Authority inspections.
• Conduct risk assessments and implement corrective actions.
• Update standard procedures to reflect current regs and trends.
• Participate in vendor selection, evaluation, and auditing.
• Provide status updates on the QMS to Leadership.
• Stay current with GCP quality surveillance and regulatory trends.

Skills

ICH Guidelines

Regulatory Knowledge

Multi-tasking

Regulatory Authorities

Attention to detail

Risk assessment

QMS

Vendor auditing

Communication

Education

Bachelor's degree or higher in science

Job description

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 safeguard product 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.

Primary responsibilities

• 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.
• Keep current with GCP quality and regulatory surveillance, as well as trends, and shares information with applicable personnel.

Primary skills and knowledge required

• 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.

Other Requirements

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%.

Education

Level of Education Required: Bachelors or Advanced degree in scientific discipline. Number of Years of Experience in the Function and in the Industry: 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.

Compensation

EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint’s compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. The target salary range for this position is listed below: Salary Range $154,500 - $195,700 USD

Company Culture

Envision Your Future With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The collective power of our values influences everything we do, and everything we do for you. Transformational Innovation We exist to change our patients’ lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology. Unwavering Integrity We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us. Compassionate Excellence We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes. Inclusive Collaboration We strive to see through the eyes of others and work as one team. We appreciate one another’s differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.

Equal Opportunity Employer Statement

EyePoint is proud to be an equal opportunity employer.

We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool.

All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.