Senior Associate Director, Clinical Quality Assurance

United States Digital Space LLC; United States; Remote; USD 140,000 - 210,000; Full time

Benefits offered by this job

Annual incentive bonus

New hire equity

Equity programs

Medical insurance

Dental insurance

Vision insurance

401k match

Flexible time off

Paid holidays

Job summary

Vera is seeking an Associate Director of Clinical Quality Assurance to partner with clinical study teams and strengthen the Quality Management System across the drug development lifecycle. You will oversee GCP/GVP/GLP compliance, investigations, CAPAs, and risk-based quality activities while collaborating with Clinical Operations, Regulatory Affairs, and CROs.

The role emphasizes proactive risk assessment, inspection readiness, and governance of SOPs and documentation.

Qualifications

• Bachelor’s degree in life sciences or related field required; advanced degree preferred.
• Approximately 8+ years of industry experience with leadership in clinical quality oversight or governance.
• Strong applied knowledge of global GxP regulations applicable to clinical development, including: Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Laboratory Practice (GLP). GMP experience not required.

Responsibilities

• Serve as Clinical Quality Assurance representative on assigned study teams to ensure trial conduct aligns with GCP and regulatory expectations.
• Provide oversight of clinical quality events, investigations, and CAPAs with root-cause analysis and corrective actions.
• Analyze quality signals across studies, vendors, and processes to identify risks and mitigation strategies.
• Govern the clinical audit program and oversee Audit CAPA follow-up (audits performed by the audit function).
• Serve as a quality interface with CROs and vendor quality representatives for issue resolution.
• Support inspection readiness activities and provide QA support during sponsor inspections.
• Review and input on SOPs and controlled documents to ensure regulatory alignment and consistency across procedures.
• Propose training assignments and matrices to ensure procedures are followed across functions.
• Participate in process improvements to strengthen the Quality Management System.

Skills

GxP knowledge

GCP

GVP

GLP

CAPA management

Audit governance

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Vera is seeking an Associate Director of Clinical Quality Assurance to partner with clinical study teams and strengthen the Quality Management System across the drug development lifecycle. You will oversee GCP/GVP/GLP compliance, investigations, CAPAs, and risk-based quality activities while collaborating with Clinical Operations, Regulatory Affairs, and CROs.

The role emphasizes proactive risk assessment, inspection readiness, and governance of SOPs and documentation.