Clinical Quality Assurance, Specialist II
Job in
San Diego, San Diego County, California, 92189, USA
Listed on 2026-09-12
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-12
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Regulatory Compliance Specialist
Job Description & How to Apply Below
The Clinical Quality Assurance Specialist will support GCP and the Quality Assurance departments to ensure compliance with GCP standards, including investigator audit programs, risk management plans, regulatory inspections, continuous improvement metrics, and quality events.
Responsibilities- Develop and maintain clinical quality study risk plans and update them in the Quality Management System.
- Collect site metrics to select investigator site audits; analyze and report trends.
- Support and lead internal audits.
- Support QMS (Veeva) audit entry and dashboard.
- Perform SOP review.
- Facilitate quality improvement by communicating audit results, CAPAs, and other quality events.
- Issue, track, and complete deviations, SCARs, and CAPAs.
- Support clinical study programs with GCP compliance, as needed.
- Support health authority inspections.
- Communicate serious or critical compliance risks to senior management (manage report of Serious Breaches).
- Stay current on related quality legislation and compliance issues.
- Support risk management analysis for GxP (primarily GCP) and assist risk identification at asset/IP, therapeutic area, study, site, and vendor levels.
- Identify KPIs for risk monitoring from internal/external sources.
- Communicate risk mitigations and activities to the Manager Clinical Quality Assurance, Quality Assurance, Clinical Operations, and Development teams.
- Bachelor’s degree in a science discipline.
- 3 years relevant experience in a regulated environment (preference: QA, auditing, and/or GCP).
- 2 years relevant experience in GCP providing Quality and Compliance oversight.
- Strong knowledge of GCP and FDA, European regulations, and ICH guidelines.
- Ability to use Veeva, Microsoft Word, PowerPoint, and Excel.
- Occasional travel to San Diego, CA;
Verona, WI;
Pasadena, CA.
- Prior Veeva/electronic document management system experience in a regulated environment.
- Knowledge of AI and/or building AI models (dataset creation, validation, reassessment).
California pay range: $80,000 USD - $95,000 USD
Candidates must have current, valid authorization to work in the country where this role is located.
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