Quality and Project Management Proven capability to manage timely delivery of GxP quality and program projects.
Aktualisiert am 16.02.2020
Profil
Freiberufler / Selbstständiger
Verfügbar ab: 01.03.2020
Verfügbar zu: 100%
davon vor Ort: 100%
Project Analysis, Planning & Controlling
Technology Transfer
GxP
Quality Control & Assurance
Build & Led High Performance Teams
Change and Deviation Management
Analytical Test Method Validation
FDA Inspection Experience
English
German

Einsatzorte

Einsatzorte

Bern (+150km)
Schweiz
nicht möglich

Projekte

Projekte

5 Jahre 6 Monate
2018-10 - heute

Laboratory Construction Project Management

  • Established laboratory requirements for chemistry, biochemistry, incoming goods, storage and stability
  • Compiled URS, acted as single point of contact for facility construction and led project team for quality
  • Managed, planned, controlled and communicated project progress and aligned activities
CSL Lengnau AG
Switzerland
5 Jahre 10 Monate
2018-06 - heute

LIMS Implementation Program Management

  • Managed and aligned activities for new LIMS locally and globally. Evaluated and established KPIs
  • Process implementation, requirement analysis and project execution planning
CSL Lengnau AG
6 Jahre 11 Monate
2017-05 - heute

Quality Control and Quality Project Management

Director Deputy
Director Deputy
  • 5 functional QC areas (40 professionals: biochemistry, chemistry, biology, development, support)
  • Responsible for SOPs, changes, deviations, investigations and strategic department programs
  • Planed and authorized budget, resources and organizational structure
CSL Lengnau AG
7 Jahre 6 Monate
2016-10 - heute

Chemical Quality Control

  • Managed 16 professionals (chemists and technicians)
  • Installed laboratories for analytics of intermediates and drug product, raw material & cleaning validation
  • Managed, planned and controlled operation readiness, elemental impurity and contract laboratories
CSL Lengnau AG
2 Jahre 1 Monat
2016-10 - 2018-10

Technology Transfer Project Management

  • Planned and managed technology transfers of test procedure for quality, production and R&D globally
  • Evaluated and Implemented raw materials and specifications at receiving unit
CSL Lengnau AG
7 Jahre 1 Monat
2009-09 - 2016-09

Assess and support

Department Deputy Head CQC
Department Deputy Head CQC
  • Assess and support change requests, deviation & complaint investigations & product submissions
  • Responsible for release testing of in-process steps, finished products (blood products) and raw materials
  • Managed resources, budget and projects and supported authority audit (FDA, Swissmedic, Health Canada)
  • Interface to R&D, production, regulatory affairs and project management
CSL Behring AG
Bern, Switzerland
8 Jahre 6 Monate
2008-04 - 2016-09

Chemical Analytical Development and Projects

  • Managed 10 professionals (chemists and technicians)
  • Develop, validate and transfer (local and global) of analytical test methods according EP, USP, JP and ICH
  • Plan and management of local and international projects with internal and external stakeholders
CSL Behring AG
1 Jahr 3 Monate
2013-04 - 2014-06

Technology Transfer Project Management

  • Transfer analytical test methods and raw material specifications globally within multi site projects
  • Evaluation of receiving and sending unit requirement, planning, controlling and communication
CSL Behring AG
1 Jahr 10 Monate
2011-01 - 2012-10

Knowledge Management

  • Initiate and implement an operative knowledge management system and trained knowledge managers
  • Requirement analysis of department, execution planning, cost benefit analysis & controlling
CSL Behring AG
2 Jahre 5 Monate
2005-11 - 2008-03

Chemical Analysis

  • Responsible for release testing of in-process steps, studies and finished products
  • Laboratory investigations, product deviations, reports, change requests
  • Procure, qualify and maintain analytical equipment for pharmaceutical testing
  • Responsible for standard operation procedures (SOPs)
  • Support and implement LIMS and paperless lab technologies (Nugenesis) for lab workflow automation
CSL Behring AG
2 Jahre 5 Monate
2003-06 - 2005-10

Human Bio Monitoring

Scientist
Scientist
  • Developed and validated test methods for specified analytes in body fluids (human bio monitoring)
  • Supported and participated in medical studies
  • Managed and evaluated third party analytics
IPASUM
Erlangen, Germany
11 Monate
1997-09 - 1998-07

Military Service

  • Medical services and field exercises
German Army

Aus- und Weiterbildung

Aus- und Weiterbildung

05/2009?08/2011

Executive MBA in Innovation Management

University Berne-Switzerland

Innovation, project & knowledge management; Modules for LIMS and Doing Business in China

Master Thesis:

Development and implementation of an operative knowledge management system

 

10/2004?03/2006

Examined Project Manager for Business Chemistry

University Muenster-Germany

Modules in competitive analysis, corporate strategies and innovation management

Thesis:

Strategic outlook for Schering?s oncology division

 

06/2003-10/2005

Doctoral Dissertation - Dr. rer. biol. hum. (PhD)

IPASUM, Erlangen-Germany

Presented and published at conferences and in scientific journals

Thesis:

Percutaneous ex vivo penetration of aromatic amines through excised human skin and influence of skin creams

 

10/1998?03/2003

Food Chemistry Studies - Diploma & First State Exam

University Kaiserslautern-Germany

Production, analysis and toxicological evaluation of food and additives

Thesis:

Metabolism of Indirubin derivatives

Kompetenzen

Kompetenzen

Top-Skills

Project Analysis, Planning & Controlling Technology Transfer GxP Quality Control & Assurance Build & Led High Performance Teams Change and Deviation Management Analytical Test Method Validation FDA Inspection Experience

Produkte / Standards / Erfahrungen / Methoden

Quality and Project Management

Proven capability to manage timely delivery of GxP quality and program projects.

Technically advanced Project Management and Quality Professional with 15 years of effective achievements providing expertise and supervision to a wide variety of projects and quality functions. Agile leader and reliable partner skilled at enabling implementation of analytical developments, operative knowledge and cross-functional software projects to increase department performance, quality, and global cooperation. Successfully established organizational structure at green field sites and managed global technology transfer.

Core Competencies:

  • Build & Led High Performance Teams
  • Quality Control & Assurance
  • Analytical Test Method Validation
  • Change and Deviation Management
  • Stakeholder Communication
  • Technology Transfer Management
  • Project Analysis, Planning & Controlling
  • FDA Inspection Experience

Additional Knowledge

  • Nugenesis
  • LIMS
  • OneNote
  • Office
  • MS Project
  • Minitab
  • Statistics
  • TrackWise

Einsatzorte

Einsatzorte

Bern (+150km)
Schweiz
nicht möglich

Projekte

Projekte

5 Jahre 6 Monate
2018-10 - heute

Laboratory Construction Project Management

  • Established laboratory requirements for chemistry, biochemistry, incoming goods, storage and stability
  • Compiled URS, acted as single point of contact for facility construction and led project team for quality
  • Managed, planned, controlled and communicated project progress and aligned activities
CSL Lengnau AG
Switzerland
5 Jahre 10 Monate
2018-06 - heute

LIMS Implementation Program Management

  • Managed and aligned activities for new LIMS locally and globally. Evaluated and established KPIs
  • Process implementation, requirement analysis and project execution planning
CSL Lengnau AG
6 Jahre 11 Monate
2017-05 - heute

Quality Control and Quality Project Management

Director Deputy
Director Deputy
  • 5 functional QC areas (40 professionals: biochemistry, chemistry, biology, development, support)
  • Responsible for SOPs, changes, deviations, investigations and strategic department programs
  • Planed and authorized budget, resources and organizational structure
CSL Lengnau AG
7 Jahre 6 Monate
2016-10 - heute

Chemical Quality Control

  • Managed 16 professionals (chemists and technicians)
  • Installed laboratories for analytics of intermediates and drug product, raw material & cleaning validation
  • Managed, planned and controlled operation readiness, elemental impurity and contract laboratories
CSL Lengnau AG
2 Jahre 1 Monat
2016-10 - 2018-10

Technology Transfer Project Management

  • Planned and managed technology transfers of test procedure for quality, production and R&D globally
  • Evaluated and Implemented raw materials and specifications at receiving unit
CSL Lengnau AG
7 Jahre 1 Monat
2009-09 - 2016-09

Assess and support

Department Deputy Head CQC
Department Deputy Head CQC
  • Assess and support change requests, deviation & complaint investigations & product submissions
  • Responsible for release testing of in-process steps, finished products (blood products) and raw materials
  • Managed resources, budget and projects and supported authority audit (FDA, Swissmedic, Health Canada)
  • Interface to R&D, production, regulatory affairs and project management
CSL Behring AG
Bern, Switzerland
8 Jahre 6 Monate
2008-04 - 2016-09

Chemical Analytical Development and Projects

  • Managed 10 professionals (chemists and technicians)
  • Develop, validate and transfer (local and global) of analytical test methods according EP, USP, JP and ICH
  • Plan and management of local and international projects with internal and external stakeholders
CSL Behring AG
1 Jahr 3 Monate
2013-04 - 2014-06

Technology Transfer Project Management

  • Transfer analytical test methods and raw material specifications globally within multi site projects
  • Evaluation of receiving and sending unit requirement, planning, controlling and communication
CSL Behring AG
1 Jahr 10 Monate
2011-01 - 2012-10

Knowledge Management

  • Initiate and implement an operative knowledge management system and trained knowledge managers
  • Requirement analysis of department, execution planning, cost benefit analysis & controlling
CSL Behring AG
2 Jahre 5 Monate
2005-11 - 2008-03

Chemical Analysis

  • Responsible for release testing of in-process steps, studies and finished products
  • Laboratory investigations, product deviations, reports, change requests
  • Procure, qualify and maintain analytical equipment for pharmaceutical testing
  • Responsible for standard operation procedures (SOPs)
  • Support and implement LIMS and paperless lab technologies (Nugenesis) for lab workflow automation
CSL Behring AG
2 Jahre 5 Monate
2003-06 - 2005-10

Human Bio Monitoring

Scientist
Scientist
  • Developed and validated test methods for specified analytes in body fluids (human bio monitoring)
  • Supported and participated in medical studies
  • Managed and evaluated third party analytics
IPASUM
Erlangen, Germany
11 Monate
1997-09 - 1998-07

Military Service

  • Medical services and field exercises
German Army

Aus- und Weiterbildung

Aus- und Weiterbildung

05/2009?08/2011

Executive MBA in Innovation Management

University Berne-Switzerland

Innovation, project & knowledge management; Modules for LIMS and Doing Business in China

Master Thesis:

Development and implementation of an operative knowledge management system

 

10/2004?03/2006

Examined Project Manager for Business Chemistry

University Muenster-Germany

Modules in competitive analysis, corporate strategies and innovation management

Thesis:

Strategic outlook for Schering?s oncology division

 

06/2003-10/2005

Doctoral Dissertation - Dr. rer. biol. hum. (PhD)

IPASUM, Erlangen-Germany

Presented and published at conferences and in scientific journals

Thesis:

Percutaneous ex vivo penetration of aromatic amines through excised human skin and influence of skin creams

 

10/1998?03/2003

Food Chemistry Studies - Diploma & First State Exam

University Kaiserslautern-Germany

Production, analysis and toxicological evaluation of food and additives

Thesis:

Metabolism of Indirubin derivatives

Kompetenzen

Kompetenzen

Top-Skills

Project Analysis, Planning & Controlling Technology Transfer GxP Quality Control & Assurance Build & Led High Performance Teams Change and Deviation Management Analytical Test Method Validation FDA Inspection Experience

Produkte / Standards / Erfahrungen / Methoden

Quality and Project Management

Proven capability to manage timely delivery of GxP quality and program projects.

Technically advanced Project Management and Quality Professional with 15 years of effective achievements providing expertise and supervision to a wide variety of projects and quality functions. Agile leader and reliable partner skilled at enabling implementation of analytical developments, operative knowledge and cross-functional software projects to increase department performance, quality, and global cooperation. Successfully established organizational structure at green field sites and managed global technology transfer.

Core Competencies:

  • Build & Led High Performance Teams
  • Quality Control & Assurance
  • Analytical Test Method Validation
  • Change and Deviation Management
  • Stakeholder Communication
  • Technology Transfer Management
  • Project Analysis, Planning & Controlling
  • FDA Inspection Experience

Additional Knowledge

  • Nugenesis
  • LIMS
  • OneNote
  • Office
  • MS Project
  • Minitab
  • Statistics
  • TrackWise

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