Lead the QA investigations to ensure compliance and effective resolution of quality events in a regulated environment while managing workflows and metrics.
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.
Key Responsibilities
- 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).
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