Senior Pharmacist, Pharmaceutical Quality & Regulatory Compliance

Pharmaceutical Quality & Compliance: GMP, GCP, GDP, GLP, ICH Quality Guidelines, FDA 21 CFR Part

11, ISO 9001, ISO 13485, Quality Management Systems, Data integrity, ALCOA+

Regulatory & Quality: Pharmaceutical Product Registration, Regulatory Compliance, Audits &

Inspections, Inspection Readiness, CAPA, Deviations, OOS/OOT, Change Control, Risk Management,

Product Recalls

Manufacturing & Product Quality: Batch/API Release, CMO Management, Technology Transfer, Product

Quality Reviews, Stability Programs, Quality Agreements, Supplier Qualification, Lean Six Sigma

Leadership & Management: Team Management, Cross-functional Leadership, Cross-functional

Stakeholder Management, Mentoring, Continuous Improvement

IT & Data: Veeva Vault, TrackWise, SAP, Novatek, GEODE, LIMS, Symphony, R, SQL, Microsoft Office,

Adobe InDesign