Chad Rutt

About Chad Rutt

Passionate, quality professional with experience promoting and sustaining a positive…

Experience

1. Director, Global Development Quality Compliance and Quality Systems

   Merck

   May 2020 — Present

   Successfully deliver divisional objectives by setting clear and aligned departmental priorities across the Compliance, Quality Systems and Learning and Development teams by ensuring teams are appropriately sponsored and resourced. Manage, maintain and enhance the Global Audit and inspection management processes, tools and systems as the Global Topic team Ensure Clinical Supply personnel are prepared to seamlessly support Health Authority inspections of Commercial Supply by partnering with the Commercial Supply Inspection Lead. Led the development and piloting of a novel, multi variate analytics too capable of proactively identifying investigations at risk of exceeding timelines. Lead post acquisition audits, provide integration recommendations to M&A and partner with subsidiaries to mitigate compliance risks

Skills

• Batch Release
• Vaccines
• Pharmacueticals
• Regulatory Affairs
• Laboratory
• Glp
• Sop
• Standard Operating Procedure (Sop)
• Quality Control
• Computer System Validation
• Gxp
• Solid Oral Dosage Forms
• Capa
• Change Control
• Regulatory Requirements
• Protein Chemistry
• Quality System
• Good Laboratory Practice (Glp)
• Corrective and Preventive Action (Capa)
• Pharmaceutical Industry
• Cleaning Validation
• Validation
• Technology Transfer
• U.s. Food and Drug Administration (Fda)
• Quality Auditing
• R&D
• Aseptic Processing
• Protein Purification
• Training
• Manufacturing
• Biopharmaceuticals
• U.s. Title 21 Cfr Part 11 Regulation
• Quality Assurance
• Biotechnology
• 21 Cfr Part 11
• Aseptic Technique
• Fda
• Gmp