Remote Associate Director — Clinical Quality Assurance

Vera Therapeutics, Inc.; United States; Remote; USD 140.000 - 210.000; Vollzeit

Zusammenfassung

Vera Therapeutics, Inc. is seeking an Associate Director, Clinical Quality Assurance to partner with clinical study teams and strengthen the quality management system during late-stage development.

This remote role offers oversight of quality events, CAPAs, and risk-based decision making across global trials. The successful candidate will lead QA activities with Clinical Operations, Regulatory Affairs, and CROs, ensuring GCP and regulatory compliance, audit readiness, and continuous improvement

Qualifikationen

• Bachelor’s degree in life sciences, pharmacy, or related scientific discipline.
• Advanced degree preferred.
• Approximately 8+ years of industry experience with leadership in clinical quality oversight.
• Global GxP regulations knowledge for clinical development.
• Experience with GCP, GVP and GLP.
• Regulatory inspection readiness and CAPA management.
• Quality governance, risk-based quality management, and audits.
• Certifications such as CQA, RAC, or RQAP are a plus.

Aufgaben

• Serve as QA representative on assigned clinical study teams with GCP/regulatory focus.
• Oversee clinical quality events, investigations, and CAPAs with root cause analysis.
• Analyze quality signals across studies and vendors to identify risks and mitigations.
• Govern clinical audit program and oversee audit CAPA follow-up.
• Interface with CROs and vendors to resolve quality issues.
• Support inspection readiness and sponsor inspections.
• Review and input on SOPs and controlled documents for regulatory alignment.
• Contribute to training matrices and governance of quality processes.
• Participate in PQMS improvements and risk-based quality management initiatives.

Kenntnisse

GCP

GVP

GLP

Audit readiness

CAPA management

Quality governance

Regulatory inspections

CQA certification

RQAP

Ausbildung

Bachelor’s degree in life sciences, pharmacy, or related scientific discipline

Advanced degree

Jobbeschreibung

Vera Therapeutics, Inc. is seeking an Associate Director, Clinical Quality Assurance to partner with clinical study teams and strengthen the quality management system during late-stage development.

This remote role offers oversight of quality events, CAPAs, and risk-based decision making across global trials. The successful candidate will lead QA activities with Clinical Operations, Regulatory Affairs, and CROs, ensuring GCP and regulatory compliance, audit readiness, and continuous improvement