Quality Assurance Specialist, Pharma & Healthcare Analytics
Overview
Own data driven quality performance systems within pharmaceutical and regulated healthcare operations at scale. Build insights from multiple data sources to drive CAPAs, deviations, and supplier quality improvements. Partner with QA leadership and Operations to align with cGMP and USP standards and support inspection readiness. This role bridges data and action to improve safety, compliance, and efficiency.
What You'll Do10
- 1Build and maintain quality metrics dashboards and scorecards for leadership and audits power bi and tableau style visualization
- 2Design and track KPIs related to CAPA cycle time, deviations, audit findings, and complaint resolution rates to enable data driven improvements
- 3Aggregate and analyze quality data from multiple systems to identify trends and process gaps for improvement opportunities
- 4Collaborate with QA leadership and Operations to implement corrective and preventive actions (CAPAs) based on root cause analysis
- 5Support regulatory audits by providing metric summaries and trend data to demonstrate compliance and readiness
- 6Standardize data collection and reporting workflows across cross functional teams to streamline metrics tracking
- 7Automate metrics reporting where feasible to improve reporting cadence and accuracy
- 8Maintain dashboards that visualize KPI performance for internal audits and leadership review
- 9Monitor regulatory alignment with cGMP, USP, and related standards and support ongoing compliance
- 10Assist in training initiatives to ensure teams understand KPIs, expectations, and improvement targets
Requirements10
- 1Bachelor’s degree in Quality Assurance, Data Analytics, Engineering, Life Sciences, or related field
- 23+ years in pharmaceutical, compounding, medical device, or regulated healthcare environments
- 3Strong understanding of Quality Management Systems (QMS) and cGMP compliance
- 4Experience analyzing and visualizing data using Excel, Power BI, Tableau, or similar platforms
- 5Familiarity with USP and 21 CFR Part 211, GDP and Good Documentation Practices (GDP)
- 6Proficient in data visualization and KPI reporting
- 7Experience with ERP and QMS software (e.g., NetSuite, MasterControl, TrackWise, Veeva)
- 8Strong analytical, organizational, and problem solving skills
- 9Excellent attention to detail and ability to interpret complex datasets
- 10Strong communication and presentation abilities across departments
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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