Dr. Ralf Schreiner

Dr. Ralf Schreiner

Pharmacist, Qualified Person

SKILLS AND EXPERIENCE

  • 18 years’ experience in leadership roles, 7 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, Canadian 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.
  • 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. 
  • Deep understanding for Quality principles and GMP compliance as well as practical application experience.
  • Comprehensive Operational Excellence understanding and knowledge through learning and application of P&G’s world-class OpEX methodology “IWS”.
  • Good understanding of Chinese culture and basic Mandarin comprehension & speaking skills through family ties and multiple visits.

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

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

  • Quality & Operational Excellence services for Life Science & other industries, Contract Audits, Inspection support, Product Quality & GMP Compliance improvement support, GMP training, Translation services, Qualified Person, Leadership team & Company board consultancy

Allergan – Executive Director Global Quality Business Transformation      (03/2015- 02/2018)

  • Member of Allergan Global QA Lead team with responsibility for establishment of QA function priorities and goals and oversight of realization.
  • Leadership for Transformation Projects of IT Systems (i.e. TrackWise, LIMS and Document Management) in collaboration with IT.
  • Identification of improvement potential for Quality Systems and processes through internal and external benchmarking and leadership of derived “Quality Best Practice” projects in collaboration with corporate OpEx group.
  • Development and Improvement of global Quality Management System through establishment, review and approval of selected global policies and procedures.

Actavis – Executive Director Quality Systems          (01/2014- 03/2015)

  • Head of Corporate Quality Systems group (3 direct and 20 indirect reports in 6 locations people located in Germany, UK, Ireland, Iceland, Canada and US) responsible for:
    • Global QMS (structure, content and implementation oversight; integration projects for QMS implementation after acquisitions).
    • Leading individual global quality processes.
    • Oversight of validation and operation of corporate level computer systems in collaboration with Corporate IT.
    • Provision of GxP/Quality Training program, training standards and processes.

Warner Chilcott – Senior Director QA Global Standards, Commercial Stability & External Operations Quality and Compliance               (07/2011 – 12/2013)

  • Head of said organization (3 direct and 35 indirect reports in 6 locations in Germany, Ireland, Spain, Puerto Rico, Canada and US) responsible for:
    • Establishment and maintenance of global components of Warner Chilcott’s Pharmaceutical Quality System (PQS) in line with Regulations and PQS implementation.
    • Quality and compliance of products manufactured at Contractors.
    • Auditing of WC operations, contractors and suppliers governed by GMP.
    • Coordination and oversight of WC’s commercial stability programs.

Warner Chilcott – Head of QA Global Standards     (09/2010 – 06/2011)

  • Head of Global Standards group (6 reports located in UK, Canada and US) responsible for:
    • Design, Implementation and Maintenance of a global Quality Management System including definition of standards and best practices.
    • Leadership for selected individual Quality systems / processes.
    • Cooperation with IT and Regulatory Affairs function.
    • Ensuring conformance of regulatory dossiers with manufacturing and testing master documents.

Procter & Gamble Pharmaceuticals – Site Quality Assurance Manager        (07/2003 – 09/2010)

  • Head of Quality Assurance department (5-7 direct and 40-45 indirect reports) responsible for:
    • Maintenance and Development of the local Quality Management System in line with evolving GMP regulations and company standards.
    • Quality Control of materials, bulk and finished products.
    • Batch Documentation review & release.
    • Inspection management.
  • Member of Site Leadership team responsible for providing direction and oversight for site operation.
  • Responsible Pharmacist / Qualified Person for selected commercial products.
  • Responsible Person for Wholesale Activities UK.

Procter & Gamble Pharmaceuticals – Head of Site Quality Assurance Systems Group         (09/2001 – 07/2003)

  • Head of said group (7-10 direct reports) responsible for:
    • Local Quality Systems (Documentation, customer complaints, APR/PQR, change control).
    • Batch Documentation Review & Release coordination.
    • Quality Control of printed packaging materials.
    • Inspection management.
  • Responsible Pharmacist / Qualified Person for local and contracted commercial products (Tablets, Capsules, Ointments, Parenterals) and bulk investigational medicinal products imported into the EU.
  • Head of Quality Control for printed packaging materials.
  • Responsible Person for Wholesale Activities UK.

Procter & Gamble Pharmaceuticals – Head of Site Product Supply Validation Group         (07/1999 – 09/2001)

  • Head of said group (4-6 direct reports) responsible for:
    • Maintenance of side-wide validation program in compliance with GMP.
    • Execution of Equipment calibration and qualification as well as Process validation studies.
    • Process trending.
    • Manufacturing Master document management.
  • Review of batch documentation and batch release as deputy Head of Production.

Procter & Gamble Pharmaceuticals – Validation and Process Development Manager    (11/1998 – 06/1999)

  • Preparation and execution of test runs and process validation studies in support of process optimization projects and product introductions
  • Investigation and documentation of deviations and non-conformances

Ludwig-Maximilians-University Munich, Germany Scientific Assistant, Department of Pharmacology and Toxicology  (09/1995 – 10/1998)

  • Member of examination commission for 3rdsection of chemistry exam (01/1999-12/1999)
  • Thesis: Research on dissolution characteristics of 2 salts of the cholinesterase reactivator HI 6 in autoinjectors

Protina GmbH, Ismaning, Germany – QC Department (Internship)       (01/1995 – 06/1995)

Einberger’s Pharmacy, Erding, Germany – Internship   (07/1994 – 12/1994)

SOCIETIES/MEMBERSHIPS

  • Landesapothekerkammer Baden-Württemberg
  • European Compliance Academy

PUBLICATIONS

H. Thiermann, R. Schreiner, P. Eyer
Dissolution kinetics of unstable drugs in two-compartment autoinjectors: Analysis of the individual shaking behavior and influence of various shaking parameters on the dissolution rate of HI 6 in an automated system.
International Journal of Pharmaceutics, 170 (1998), 23 – 32.

PROFESSIONAL DEVELOPMENT

  • Concept Heidelberg – Organization and Documentation of Validation and Qualification according to PIC PH 1/96 and FDA Requirements 1998
  • Procter & Gamble – Validation Training 1999
  • Procter & Gamble – 3-day High Performance Organization Training 1999
  • Procter & Gamble – 5-day Quality Assurance Key Element Course 1999
  • European Compliance Academy – Electronic Document Management Systems 2000
  • APV – Basic Training Computer Validation & CFR Part 11 Compliance 2001
  • Colloquium Pharmaceuticum – Separation of Responsibilities and Liabilities according to German Drug Law 2001
  • Procter & Gamble – Statistical Principles & Methods 2001
  • Procter & Gamble – The 5 E Leadership Modell 2001
  • Procter & Gamble – 3 E Leadership Training 2001
  • Procter & Gamble – Total Quality 2001
  • Procter & Gamble – Multiple Trainings on P&G’s OpEx Methodology IWS (Integrated Work Systems) and its Pillars 2001-2007
  • PCS – Annex 16 – QP-Batch Release 2002
  • Concept Heidelberg – Statistics for Pharma Production, Quality Control and Quality Assurance 2002
  • ISPE – Regulatory Expectations for Utility Systems 2003
  • Procter & Gamble & Globepharm Consulting – Compliance Fundamentals 2003
  • Hoffmann, Liebs, Fritsch & Partner – Environmental, Work and Product Safety Fundamentals 2004 & 2009
  • Procter & Gamble – Finance for non-F&A’s: Finance Basics 2004
  • Procter & Gamble – Root Cause Analysis 2004
  • Procter & Gamble – Start-up Leader Training 2005
  • Procter & Gamble & Globepharm Consulting – Effective Investigations and Corrective Actions (CAPA) 2006
  • Procter & Gamble – FDA Principles/Expectations and new challenging Concepts in GMP Regulation and Compliance 2006
  • European QP Association – 3rd QP Forum 2008
  • Procter & Gamble – Pharma University 2009
  • Collaro Inc., Human Reliability Consultancy – Human Error Workshop 2010
  • Provadis – GMP Forum 2010
  • Concept Heidelberg – Drug Product Registration in the EU and the US 2011
  • DBA International Healthcare – Practical Implementation of Quality by Design (QbD)10 und NSF 2011
  • Concept Heidelberg – 2nd Merck Pharma Forum 2011
  • European Compliance Academy – Continuous Quality Improvement 2012
  • Management Circle – Top Reports in Quality Management 2012
  • Management Circle – Leading with Consequence 2012
  • Management Circle – Leading Teams without disciplinary Authority 2013
  • European QP Association – QP Forum 2013
  • Management Circle – Leading from a distance: Manager of a virtual Team 2014
  • Concept Heidelberg – PharmaLab: Analytics, Bioanalytics and Microbiology 2015
  • Warner Chilcott Deutschland GmbH – Energy Management according to DIN EN ISO 500001 2015
  • Luther – Data Security for Management 2016
  • European Compliance Academy – GMP Compliance for Biopharmaceuticals and GMP Requirements for ATMPs 2016
  • Compliance Trainings  – Webinar Good Manufacturing Practices  for Medical Devices 2016
  • European Compliance Academy – Quality Risk Management 2017
  • Concept Heidelberg – The GMP Auditor & The Lead Auditor 2018

LICENCES/CERTIFICATIONS

Germany, Bayern (Bayerisches Staatsministerium für Arbeit und Sozialordnung, Familie, Frauen und Gesundheit) – 07/1995
Approbation as Pharmacist

Germany, Hessen (Regierungspräsidium Darmstadt) – 09/2005 – 08/2008
Head of Quality Control / Qualified Person for Procter & Gamble Pharmaceuticals-Germany GmbH

Certified GMP Auditor – 06/2018