Nathan W.

Background

About Nathan W.

How can we empower ourselves and those around us to do the right thing even when nobody else is watching or paying attention? That’s the question I ask myself every day in this line of work. I am a Technically versed, passionate leader with almost eight years of Operations and Quality Assurance leadership experience across four segments of the Pharmaceutical Supply Chain. My product experience includes: 1) Manufacturing and Supply of Pharmaceutical Raw Ingredients/Materials, 2) Commercial and contract manufacturing of Class I/II Medical Devices, 3) Commercial manufacture of Solid Dose Pharmaceuticals, and 4) Commercial-Phase Autologous CAR-T cellular therapy. My work ethic, education, and technical focus has provided me with a keen ability to listen, understand, digest, and convey complex information in easy-to-understand formats for targeted audiences without losing key details along the way. Coupled with an intense focus on critical thinking and omnipresent quality-oriented leadership, my technical expertise provides a unique competency set fit for purpose in any regulated environment. Even though I have occupied roles on each side of the Quality and Operations fence, my true passion lies in Quality. Despite the acknowledged passion, my foundational experience in operations has taught me the critical importance of effective cooperation between operations and quality units as we all strive towards the collective goal of improving lives of patients, together, one day at a time. I have a thorough knowledge of Root Cause Analysis, QMS Structure, Manufacturing/Packaging Investigations, Lab OOS, End to End CAPA Lifecycle Management, Supplier Qualification, Internal Auditing, ICH Risk-Based Decision Making, Customer Complaint Handling, Attribute and Variable Inspection Plans (ANSI/ASQ z 1.4/1.9), Mock Recalls using SAP end to end traceability, Intermediate Level Biostatistics, SPC/Control Charting & Process Capability, Data Visualization/Analysis using JMP/Excel/R/Minitab, and eQMS platforms including Veeva Vault (VEEV), Trackwise (HON), and home-grown QMS solutions leveraging the Salesforce (CRM) platform. Before you go, I also think the skills and experience I have make me know how to ask a lot of the questions you aren’t currently asking yourselves about your quality system and how you do things. Noodle on that. Recipe for Success: 1) Right People 2) Right Skills 3) Right Places 4) Right Time #PatientsFirst #QualityAlways