Remote 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

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.