Jens Schenk

Freiberuflich, Pharma & GMP Consultant, Independent Consultant

Fähigkeiten und Kenntnisse

CAPA
Analytical Chemistry
Change Control
Analytische Chemie
Chemie
Änderungskontrolle
Chromatography
Audits
KI für Unternehmen
Coaching
Auftragsfertigung
Biopharmaceuticals
KI im Projektmanagement
Computervalidierung
Biopharmazeutika
Künstliche Intelligenz (KI)
Fertigung
Pharmaceutical Industry
Biotechnologie
Laborkenntnisse
GMP
Pharmaindustrie
GxP
Lebensmittelüberwachung
Pharmazeutische Fertigung
ISO
LIMS
Problemlösung
Quality System
Medizinprodukte
Projektmanagement
Quality System Compliance
Microsoft 365
Qualitätsaudit
SOP
Microsoft Copilot
Qualitätskontrolle
Technologietransfer
Operative Exzellenz
Qualitätsmanagementstandards
Technology Transfer
Validation
Qualitätsmanagementsystem
Veränderungsmanagement
Qualitätssicherung

Werdegang

Berufserfahrung von Jens Schenk

  • Bis heute 1 Monat, seit Okt. 2026

    Pharma & GMP Consultant

    Independent Consultant

    GMP Compliance, Auditsupport, Coaching / Mentoring, Quality Systems, Problem Solving, Projects

  • 4 Jahre und 9 Monate, Okt. 2021 - Juni 2026

    Associated Director Supplier and ECM Quality

    Baxter International Inc.

    Responsible for the Supplier and ECM Quality Team Europe, Middle East and Africa Strengthened supplier qualification and risk management strategies across EMEA (120 countries in total) in addition.

  • 1 Jahr und 11 Monate, Nov. 2019 - Sep. 2021

    Senior Quality and ECM Manager - leading Team Europe, Middle East and Africa

    Baxter International Inc.

    Responsible for the Supplier Quality and ECM Quality team EMEA (Europe, Middle East and Africa) - Led and executed 200+ audits in accordance with ISO 9001, ISO 13485, GMP, GDP, and GLP. - Successfully restructured SQA and ECM processes, increasing efficiency by 25% while maintaining full compliance. - Managed and developed international and virtual teams across multiple regions.

  • 1 Jahr und 3 Monate, Sep. 2018 - Nov. 2019

    Operational Excellence Lead

    Baxter International Inc.

    Working especially for CMO relationships, Supplier Quality Process Improvements and Global Process Improvements. - Redesigned the global new supplier qualification process, shortening lead time by 55 %. - Implemented a standardized global quality due diligence framework and playbook. - Improved transparency and alignment of supplier risk assessments (supplier scorecard).

  • 5 Jahre und 5 Monate, Mai 2013 - Sep. 2018

    Senior Manager Country QA Germany - Austria - Switzerland

    Baxter International Inc.

    Responsible for Country Quality Assurance and distribution QA. - Oversaw QA activities for distribution in DACH. - Acted as Stufenplanbeauftragter (technical) and key contact for regulatory matters. - Ensured full GDP compliance across the distribution network. - Implemented validated passive temperature-controlled delivery systems for the last mile. - Supported BioScience ECM interface and quality governance. Working in parallel as Responsible Person for Baxalta Germany (ad interim, May 2015 - Jan 2016) t

  • 14 Jahre und 1 Monat, Apr. 1999 - Apr. 2013

    Head of Quality Unit

    Octapharma

    Overall responsibility for QA, QC, QiO and Plasma QA. - Ensured regulatory compliance and site-wide quality governance. - Ensured approval by European, Asian and American authorities (as well as customers). - Harmonized local standards with global Octapharma requirements. - Qualified to act as Qualified Person (QP) for biologics.

  • 7 Jahre, Apr. 1999 - März 2006

    Head QA

    DRK - Plasmaverarbeitungsgesellschaft

    Responsible for QA and QA plasma , Company was acquired by => see next position

  • 1991 - 1999

    Head of QC laboratories

    BF Goodrich Diamalt

Ausbildung von Jens Schenk

  • 8 Monate, Apr. 2019 - Nov. 2019

    Six Sigma Green Belt

    Baxter

    Baxter internal training with graduation

  • 2009 - 2015

    Bachelor of Ministry

    Vision International College and Seminary

    extra-occupational

  • 1987 - 1991

    Dipl. Ing. (FH) Chemie

    Naturwissenschaftlich - Technische Akademie Prof. Dr. Grübler Isny

  • 1984 - 1986

    CTA 1,4

    Kolleg der NTA Prof. Dr. Grübler, Isny

Sprachen

  • Deutsch

    C2 (Verhandlungssicher / Muttersprachlich)

  • Englisch

    C2 (Verhandlungssicher / Muttersprachlich)

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