Sefany Stellakis

Experience

1. Director, Product Quality Lead Marketed Products, Bio Sterile

   Bristol-Myers Squibb

   Nov 2023 — Present · MA, US

   Serves as a direct manager with oversight of other QPLs execution of work objectives,performance, and coaching. Drives strategic improvement imperatives for the Global Quality organization leveraging quality risk management principles. Develops and implements strategies to evaluate the health of commercial brands.Works as a strategic partner with the Senior Director of Product Lifecycle ProductQuality, the QPL team and other Global Quality Leaders & functions, Manufacturing andScience & Technology, QC and Analytical Sciences, Global Supply Chain, GlobalRegulatory CMC, and/or CMC team members to ensure continuity of supply,interconnectivity, continuous improvements of ways of working, review and discussionoverall health of the products, and end-to-end optimization across the brand Lifecycle.Responsible for delivering against commercial brand(s) and the Global Qualityfunction goals and objectives. Provides strategic proposals for the post market brand lifecycle of the commercial brands in scope of responsibility.Acts as the core Quality member of the global Operations team (GO) serving as the single point of contact for the commercial brand, responsible and accountable to the brand team for overall success against the strategic plan (lifecycle, footprint, markets, format, risks, business continuity).Responsible for of the Commercial Brand Scorecards including continuous monitoring, data analysis, and reporting, leveraging the Quality systems and brand technical knowledge.Executes recommend actions to improve brand Quality Health Scorecards based off data and trending.Owner of the global change management implementation strategy, end-to-end preapproval inspection and launch readiness, responsibility for RFT initial applications and post approval supplements for the late-stage early assets and Commercial brands.

Education

• Bates College

  B.S., Biochemistry

  1994 — 1997