Associate Director, Clinical Quality Assurance
V
Vera TherapeuticsBiotechnology
Location: RemoteFull-TimeManager
Salary$140,000 — $210,000 USD
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Job Details
- Experience
- 8+ years of industry experience
- Required Skills
- GCPRisk Management
Requirements
- Bachelor’s degree in life sciences, pharmacy, or related scientific discipline required; advanced degree preferred.
- Approximately 8+ years of industry experience, including leadership in clinical quality oversight or quality governance.
- Strong applied knowledge of global GxP regulations applicable to clinical development, including GCP, GVP, and GLP.
- Experience with quality management and oversight of clinical trials.
- Demonstrated experience with quality event and CAPA management.
- Experience with regulatory inspection readiness and inspection support.
- Knowledge of risk-based quality management approaches.
- Experience planning clinical audits and developing quality metrics.
- Proficiency in SOP governance through controlled document reviews.
- Experience with training matrix or training governance activities.
- Relevant certifications such as RQAP, CQA, CCRC, or RAC are considered a plus.
Responsibilities
- Serve as the Clinical Quality Assurance representative on assigned clinical study teams, providing proactive guidance to ensure clinical trial conduct aligns with GCP and regulatory expectations.
- Provide oversight of clinical quality events, investigations, and CAPAs, ensuring appropriate root cause analysis, corrective actions, and identification of systemic quality trends.
- Analyze quality signals across studies, vendors, and operational processes to identify emerging risks and recommend mitigation strategies.
- Contribute to governance of the clinical audit program, including risk-based selection of audits and oversight of Audit CAPA follow-up.
- Serve as a quality interface with CROs and vendor quality representatives to ensure appropriate management and resolution of quality issues.
- Support inspection readiness activities and provide first-line Clinical QA support during sponsor regulatory inspections.
- Review and provide input on new or revised SOPs and controlled documents to ensure alignment with regulatory requirements.
- Provide input on training assignments and training matrices to ensure procedures are appropriately implemented across functional roles.
- Participate in process improvement initiatives that support the development and strengthening of the Quality Management System.
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