Minimum education and years of relevant work experience: Bachelors degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or a related scientific discipline and minimum 5 years in quality systems, process validation, product quality review or quality engineering in the pharmaceutical or biotechnology industry in positions of increasing technical responsibility OR combination of education and related quality systems, process validation, product quality review or quality engineering in the pharmaceutical or biotechnology industry in positions of increasing technical responsibility. Analyzes and interprets large datasets from Manufacturing, Packaging, Laboratory departments, complaints, deviations, Corrective Action Preventive Action (CAPAs), change controls and stability programs to identify statistically significant trends, process shifts and emerging quality risks including, but not limited to: analyzing Deviation and Rejection Profiles, trending manufacturing deviations, batch failures, yield losses and Out-of-Specification (OOS) laboratory findings (i.e., dissolution, uniformity, particle size), etc.