Dr. Anke von Harpe

Dr. Anke von Harpe

Pharmacist, Qualified Person

SKILLS AND EXPERIENCE

  • 15 years experience in leadership roles, 6 years leading virtual teams across multiple countries and time zones.
  • Comfortable in intercultural environments, with excellent communication and interpersonal skills, quick learning curve and strong organizational capabilities and flexibility.
  • Fluent in English (verbal/writing) through 20+ years of experience in bilingual environment and collaboration with partners in European and US units.
  • Excellent writing and presentation skills (German/English) in written, direct interaction and virtual communication setups.
  • Experience in local roles (QA, QC, Quality Systems, Qualified Person) as well as corporate QA Roles and various corporate environments ranging from 3000 to >40.000 employees worldwide.
  • Comprehensive Operational Excellence understanding and knowledge through learning and application of P&G’s world-class OpEX methodology “IWS”.
  • First hand experience in corporate Quality Management System development across multi-national company networks, integration of systems through mergers and acquisitions, and leading implementation of global requirements both at the site level, as well as rolling out corporate systems throughout the company.

 

PROFESSIONAL EXPERIENCE

QProgress – Pharma and LifeScience Quality Consulting & Services    09/2018 – present

  • Quality & Operational Excellence consulting & services for Life Science & other industries including, but not limited to:
    • Planning, integration, review and optimization of Quality Systems
    • Contract Audits
    • Inspection support
    • Product Quality & GMP Compliance improvement support
    • GMP training
    • Translation services
    • Qualified Person
    • Leadership team & Company board consultancy
    • Speaker for European Compliance Academy, EU QP Association and Concept Heidelberg

vonHarpe Consulting – Independent Consultant        03/2018 – 09/2018

  • Quality Systems, QMS, Contract Audits, GMP training, Translation services, Qualified Person

Allergan – Director Quality Systems       (03/2015- 02/2018)

  • Head of Quality Systems group (13 people located in Germany, UK and US):
  • Global QMS (structure, content and implementation oversight).
  • Corporate documentation for Actavis PLC worldwide.
  • Integration projects for QMS implementation after acquisitions.

Actavis – Director Quality Management System          (02/2014- 02/2015)

  • Head of Quality Management System group (8 people located in Germany, UK, Iceland, Canada and US):
  • Global QMS (structure, content and implementation oversight).
  • Corporate documentation for Actavis PLC worldwide.
  • Integration projects for QMS implementation after acquisitions. 

Warner Chilcott –  Head of Global Standards     (12/2012 – 01/2014)

  • Head of Global Standards group (6 people located in UK, Canada and US), managing global quality systems & IT quality oversight for Warner Chilcott worldwide.
  • Global Owner for Change Management System, Customer Complaints System, Global Quality Management System. 

Warner Chilcott – Global Standards Manager         (09/2011 – 12/2012)

  • Global Owner for: Change Management System, Customer Complaints System, Global Quality Management System.

Warner Chilcott – Contract Manufacturing & Clinical Supplies QP /QA Manager     (06/2010 – 09/2011)

  • Responsible Pharmacist / Qualified Person various contracted products (Tablets, Medicated Foam, Suppositories).
  • Quality oversight for the contract manufacturer/packager.
  • QP certification for bulk investigational medicinal products imported into the EU.
  • Global Change Management System Owner.

Procter & Gamble Pharmaceuticals – Contract Manufacturing & Clinical Supplies QP /QA Manager        (02/2008 – 06/2010)

  • Responsible Pharmacist / Qualified Person various contracted products (Tablets, Capsules, Parenterals).
  • Quality oversight for the contract manufacturer/packager
  • QP certification for bulk investigational medicinal products imported into the EU

Procter & Gamble Pharmaceuticals – Quality Assurance Systems Group Manager         (07/2003 – 06/2007)

  • Responsible Pharmacist / Qualified Person for local and contracted products (Tablets, Capsules, Parenterals)
  • Head of Quality Control for printed packaging materials
  • Local Quality Systems (Documentation, customer complaints, APR/PQR, change control)

Procter & Gamble Pharmaceuticals – Quality Control Systems Manager    (09/2000 – 07/2003)

  • Local Stability Program, APR/PQR, Environmental Monitoring, Microbiological Method Validation, Cleaning Validation, Site Facility Projects.
  • Backup for Lab Manager and for Head of Quality Control

Philipps-University Marburg, Germany –  Scientific Assistant, Department of Pharmaceutical Technology  (01/1997 – 07/2000)

  • Student tutorials for sterile, solid and semisolid dose forms
  • Member of audit commission for 2ndsection of pharmaceutical exam (01/1999-12/1999)
  • Thesis: Polyethylenimine derivatives for targeted gene transfer:
    Synthesis, coupling of ligands and interactions with DNA

Pelikan Pharmacy, Mannheim, Germany – Internship   (05/1996 – 11/1996)

Hoechst AG, Frankfurt, Germany – Galenics Department (Internship)       (12/1995 – 05/1996)

 

SOCIETIES/MEMBERSHIPS

  • Landesapothekerkammer Baden-Württemberg
  • European Compliance Academy
  • EU QP Association

 

PUBLICATIONS

v. Harpe, H. Petersen, Y. Li and T. Kissel
Characterization of commercially available and synthesized polyethylenimines for gene delivery.
Journal of controlled release, 69 (2000), 309-322.

Fischer, A.v.Harpe and T. Kissel
Polyethylenimine: Polymer Structure Influences the Physicochemical and Biological Effects of Plasmid/PEI Complexes.
In: K.D. Park, I.C. Kwon, N. Yui, S.Y. Jeong and K. Park (eds.)
Biomaterials and Drug Delivery toward new Millennium, 2000, 195-211.

Kunath, A. v. Harpe, H. Petersen, D. Fischer, K-H. Voigt, T. Kissel, U. Bickel
The structure of PEG-modified Poly(Ethylene Imines) Influences Biodistribution and Pharmacokinetics of Their Complexes with NF-κB Decoy in Mice.
Pharmaceutical Research, Vol. 19, No. 6, June 2002.

Kunath, A.v. Harpe, D. Fischer, T. Kissel
Galactose-PEI-DNA complexes for targeted gene delivery: degree of substitution affects complex size and transfection efficiency.
Journal of controlled release, 88 (2003), 159-172.

Kunath, A. v. Harpe, D. Fischer, H. Petersen, U. Bickel, K.-H. Voigt, T. Kissel
Low-molecular-weight polyethylenimine as a non-viral vector for DNA delivery: Comparison of physicochemical properties, transfection efficiency and in vivo distribution with high-molecular-weight polyethylenimine.
Journal of controlled release, 89 (2003), 113-125.

 

PROFESSIONAL DEVELOPMENT

  • Procter & Gamble Focused Improvements 7 Step Workshop 2000
  • Procter & Gamble 5 day Quality Assurance Key Element Course 2001
  • APV – Production Plants for Purified Water 2001
  • Haus der Technik – Safety for Laboratories 2001
  • Concept Heidelberg – Good Hygiene Practices in Pharma Production 2001
  • Vision in Business – Global Cost Effective Stability Testing 2002
  • Pharmaceutical Consultancy Services – Annex 16 – Qualified Person – Batch Release 2002
  • APV – Cleaning Validation 2002
  • ISPE – Renovation of Pharmaceutical Facilities 2003
  • Concept Heidelberg – Annual Product Review 2005
  • FORUM – Qualified Person Training 2006
  • Regierungspräsidium Darmstadt – GMP Symposium 2008
  • FORUM – Legislation Background for Investigational Medicinal Products 2008
  • FORUM – GMP Contracts 2009
  • FORUM – Production Driven Post-Approval Changes 2010
  • European QP Association – QP Forum 2011
  • Management Circle – Intercultural Quality Management 2012
  • Warner Chilcott Leadership Development Program 2013
  • European Compliance Academy – Change Control 2013
  • European Compliance Academy – GMP for Medical Devices 2015
  • European Compliance Academy – GMP meets Development 2016
  • European Compliance Academy – Quality Oversight 2016
  • Concept Heidelberg – The GMP Auditor & the Lead Auditor 2018
  • European Compliance Academy – Quality Risk Management Summit 2018
  • European Compliance Academy – Inspection Management 2018 & 2019 (Speaker)
  • European QP Association – QP Forum 2019 (Speaker)
  • Concept Heidelberg – The GMP Auditor 2019 (Speaker)
  • Concept Heidelberg – Schlanke GMP Systeme 2020 (Speaker)

LICENCES/CERTIFICATIONS

Germany, Baden-Württemberg (Regierungspräsidium Stuttgart) – 12/1996
Approbation as Pharmacist

Germany, Hessen (Regierungspräsidium Darmstadt) – 07/2003
Qualified Person for Warner Chilcott Deutschland GmbH

ECA Certified Quality Assurance Manager – 06/2018

Certified GMP Auditor – 06/2018