William Kentrup

About William Kentrup

Strategic thinking and positioning to drive Quality systems and holistic approaches to drive \"best in class\" performance. This role is providing governance and building site capability by establishing one Quality Management System for global Takeda from the legacy companies and driving implementation of revised e-systems across the network. In legacy roles, have lead efforts to transform Quality systems and engage externally to drive proactive engagement and risk based approaches for Quality.Previously, I was heavily engaged in providing leadership in remediation of North America sites and establishing a positive trajectory of improvement while contributing to building a culture of Quality across site networks.From my historical roles, I have diverse Global Quality experience having worked at sites in Puerto Rico, United Kingdom, Ireland, France, Mexico, and South Africa; Directed overall Quality Operations at a site level as well as across a global network; Lead efforts to drive European Product Compliance-Regulatory- efforts while based in Newbridge Ireland;Provided leadership in successful remediation efforts at various global sites while maintaining positive working relationships with the respective Boards of Health -(FDA, EMEA,IMB)Demonstrated success in implementation of Quality by Design for Analytical Methodology while integrating Process Analytical technologySpecialties: Effective utilization of Knowledge management tools to advance Quality by Design; Provided leadership in designing and advancing \"Lean Labs / Lab Excellence\" across site networks.

Experience

1. SVP Quality Compliance and Systems

   Takeda

   Sep 2015 — Present · Boston, MA, US

Education

• Northern Kentucky University

  BS Chem, chemistry

  1976 — 1981

• Northern Kentucky University

  BS degree, Chemistry

  1977 — 1981

Skills

• Quality Management
• 21 Cfr Part 11
• Formulation
• Gas Chromatography
• Regulatory Requirements
• Standard Operating Procedure (Sop)
• Dissolution
• Biotechnology
• Cleaning Validation
• Pharmaceutical Industry
• Sop
• Fda
• Validation
• Iso 13485
• Capa
• Drug Delivery
• Fda Gmp
• Lims
• Laboratory
• Drug Development
• Biopharmaceuticals
• Glp
• Usp
• Hplc
• Cmc
• Quality by Design
• Quality System
• V&V
• Technology Transfer
• Quality Control
• Trackwise
• Gmp
• Computer System Validation
• Pharmaceutics
• Gxp
• Quality Auditing
• Aseptic Processing
• Quality Assurance
• Regulatory Submissions
• Change Control