William (Al) Kentrup

William (Al) Kentrup Email and Phone Number

Driving Proactive Quality Systems and Compliance @ Takeda
William (Al) Kentrup's Location
Loveland, Ohio, United States, United States
William (Al) Kentrup's Contact Details

William (Al) Kentrup personal email

n/a

William (Al) Kentrup phone numbers

About William (Al) 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.

William (Al) Kentrup's Current Company Details
Takeda

Takeda

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Driving Proactive Quality Systems and Compliance
William (Al) Kentrup Work Experience Details
  • Cispac
    President, Owner
    Cispac Jun 2024 - Present
    Compliance, Integrity, Systems, Proactive Assessments, Culture
  • Career Break
    Retirement
    Career Break May 2024 - Present
  • Takeda
    Svp Quality Compliance And Systems
    Takeda Sep 2015 - Present
    Tokyo, Jp
  • Procter & Gamble
    Worldwide Director Corporate Quality
    Procter & Gamble Dec 2012 - Sep 2015
    Cincinnati, Ohio, Us
    Corporate Center Quality
  • Sandoz Pharmaceuticals
    Vp Quality Of North America
    Sandoz Pharmaceuticals Dec 2010 - Dec 2012
    Basel, Basel-Stadt, Ch
    Provide strategic direction in improving Operational Quality and Compliance across 3 North America sites and External Supply Network; Actively engaged with Sandoz-Novartis Global Quality Organizations to drive Global Quality programs and Sustainable Compliance
  • Pfizer
    Vp Manufacturing And Supplier Quality Assessments
    Pfizer Oct 2009 - Dec 2010
    New York, New York, Us
    Integrated legacy Wyeth and Pfizer Global Quality and Compliance Auditing groups to establish a combined group with a focus on Supplier Quality and Assessment programs;
  • Pfizer
    Vp Global Quality Analytical And Technical Operations
    Pfizer Jun 2007 - Oct 2009
    New York, New York, Us
    Established Central and Site based Analytical Development teams to support current Marketed products as well New Product introductions; Developed and supported Process Analytical Technology
  • Pfizer
    Vp Quality - Pharmaceutical Operating Unit
    Pfizer Aug 2004 - Jun 2007
    New York, New York, Us
    Directed overall Quality Operations for 8 global sites;
  • Pfizer
    Avp Quality Business Processes - Laces
    Pfizer Aug 2003 - Sep 2004
    New York, New York, Us
    Directed overall global Quality implementations of automated data acquisition and infomration management systems
  • Kansas City Quality
    Quality Operations Director
    Kansas City Quality Oct 2001 - Aug 2003
    Leader of overall Quality Operations for Kansas City Industrial OperationsImplement Global Quality Standards and Quality Council processImproved FTQ from 89% > 98%Implemented revised Change Control ProcessImplemented tools for assessing Cost of Quality - Cost of Non-QualityProvided Compliance support and acted as interim Head of Quality at the Aventis Holmes Chapel site in the United KingdomInterfaced and worked at multiple sites; to review, coordinate and support systematic improvements;Extensive knowledge/experience in Process Validation, Cleaning Validation, Investigations/Deviations and Method Validation;Participated in Regulatory Agency inspections (FDA, MCA, etc) at sites
  • Sanofi-Aventis
    Site Director Quality
    Sanofi-Aventis 2001 - 2003
    Paris, France, Fr
  • Aventis - External Manufacturing
    Quality Operations Director
    Aventis - External Manufacturing Sep 2000 - Oct 2001
    Established goals and directions for the External Quality unitManaged introduction of new product from Proctor & GambleProvided leadership in identifying External Quality's role within NA.Conducted Risk Based Analysis of Third Party contractors
  • Hoechst Marion Roussel - Finished Products
    Laboratory Manager
    Hoechst Marion Roussel - Finished Products Sep 1994 - Sep 2000
    Implemented 2nd shift Lab TeamImplemented Metric systems - Goal Attainment; Key Performance IndicatorsParticipated with FDA in developing draft guidance on procedure for handling of OOS resultsEstablished Career Guidelines to assist analysts in career planningParticipated in Cycle Time Reduction Teams; Established measurements/tracking systemsPrinciple leadership in implementing " Deviation" and "OOS" program;Worked at various foreign sites to improve QA/QC operations; sites included
  • Marion & Company
    Laboratory Advisor
    Marion & Company May 1992 - Sep 1994
    Provided leadership to QC laboratories; Design, purchased, and implemented site chromatographic data acquisition system, (PeakPro-by Beckman Instruments, Vax based)Provided support to Site Quality Director; Participated in FDA inspections and defended lab operations;Hired future staff of lab supervisors and managers
  • Manati Puerto Rico
    Interim Qa Leader
    Manati Puerto Rico May 1992 - Aug 1994
  • Merrell-Dow
    Analytical Development Chemist
    Merrell-Dow Feb 1990 - Jun 1992
    Developed analytical methods for solid oral dosage formsDeveloped and validated an automated method using Zymark automated workstationProvided remote support for method troubleshooting in Mexico and Canada
  • Merrell-Dow Pharmaceuticals
    Dissolution Team Leader
    Merrell-Dow Pharmaceuticals Aug 1986 - Feb 1990
    Supervised a team of 12 analysts performing routine QC testing Participated in Dissolution calibrator testing for USP; Drafted position paper to eliminate routine salicylic acid and prednisone tablets; Achieved reduced testing
  • Merrell- Dow Pharmaceuticals
    Chromatography Chemist
    Merrell- Dow Pharmaceuticals May 1983 - Aug 1986
    Perform routine testing of raw materials, drug product, drug substances, using HPLC / GCSupport site validation projects on an as needed basis

William (Al) Kentrup Skills

Gmp Validation Fda Change Control Pharmaceutical Industry Quality Assurance Capa Quality System V&v Technology Transfer 21 Cfr Part 11 Quality Auditing Analytical Chemistry Sop Cleaning Validation Regulatory Affairs Quality Control Dissolution Quality Management Glp U.s. Food And Drug Administration Gxp Hplc Biopharmaceuticals Pharmaceutics Computer System Validation Continuous Improvement Chromatography Lims Gas Chromatography Standard Operating Procedure Biotechnology Contract Manufacturing R&d Regulatory Submissions Trackwise Fda Gmp Laboratory Regulatory Requirements Formulation Aseptic Processing Corrective And Preventive Action Drug Delivery Usp Drug Development Quality By Design Verification And Validation Cmc Iso 13485

William (Al) Kentrup Education Details

  • Northern Kentucky University
    Northern Kentucky University
    Chemistry
  • Northern Kentucky University
    Northern Kentucky University
    Chemistry

Frequently Asked Questions about William (Al) Kentrup

What company does William (Al) Kentrup work for?

William (Al) Kentrup works for Takeda

What is William (Al) Kentrup's role at the current company?

William (Al) Kentrup's current role is Driving Proactive Quality Systems and Compliance.

What is William (Al) Kentrup's email address?

William (Al) Kentrup's email address is wi****@****doz.com

What is William (Al) Kentrup's direct phone number?

William (Al) Kentrup's direct phone number is +1 224 554*****

What schools did William (Al) Kentrup attend?

William (Al) Kentrup attended Northern Kentucky University, Northern Kentucky University.

What skills is William (Al) Kentrup known for?

William (Al) Kentrup has skills like Gmp, Validation, Fda, Change Control, Pharmaceutical Industry, Quality Assurance, Capa, Quality System, V&v, Technology Transfer, 21 Cfr Part 11, Quality Auditing.

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