QA Investigations Lead with strong expertise in process investigations, capable of managing cross-functional teams, driving data-driven decision making, and establishing performance metrics (KPIs) to enhance investigation efficiency, compliance, and continuous improvement within GMP-regulated environments.
The selected candidate will be responsible for managing investigation workflows, tracking key metrics, leading cross-functional meetings, and challenging teams to ensure thorough root cause analysis and sustainable corrective actions.
- Lead and manage the Quality Investigation System.
- Supervise and develop Data Reviewers team.
- Conduct daily triage meetings and weekly investigation status reviews.
- Ensure timely assignment, execution, and closure of investigations.
- Prepare and present monthly quality metrics to site.
Requirements
- Bachelor’s Degree in Sciences
- 10+ years of QA experience in the pharmaceutical industry.
- Strong knowledge of cGMP and quality systems.
- Proficiency in TrackWise, SAP, MS Office.
- Excellent communication skills in English and Spanish (speak, understand and write).
Skills Required
- Bachelor's Degree in Sciences
- 10+ years of QA experience in the pharmaceutical industry
- Strong knowledge of cGMP and quality systems
- Proficiency in TrackWise, SAP, MS Office
- Excellent communication skills in English and Spanish
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
