Senior Director, Head of Quality Cardiopulmonary
Getinge AB
Schlagwörter
Qualitätsmanagement
Skills
GMP
QA
QMS Pharma
QMS Medizintechnik
Prozessvalidierung
Reinigungsvalidierun
Qualitätsrisikomanagement
QA
QMS Pharma
QMS Medizintechnik
Prozessvalidierung
Reinigungsvalidierun
Qualitätsrisikomanagement
Projekthistorie
01/2021
-
05/2023
Active and Non-Active Medical Devices
* Management of the quality and regulatory organization
Cardiopulmonary with 170 employees at the sites in
Hechingen, Bodelshausen, Rastatt and Antalya-Turkey
with 7 Directs
* Responsible Person for Regulatory Requirements
(PRRC) according to Art. 15 MDR for the business unit
Cardiopulmonary
* Quality Management Representative at the
manufacturing site in Hechingen Germany, production
Disposables Cardiopulmonary
* Board Member of the management team of the
Cardiopulmonary business unit
* Quality Lead for MDR implementation
* Management of the FDA inspection preparations at the
sites in Hechingen, Bodelshausen and Rastatt -
Leading remediation program due Consent Decree
* Managing Change of the Notified Body
* Management of the quality and regulatory organization
Cardiopulmonary with 170 employees at the sites in
Hechingen, Bodelshausen, Rastatt and Antalya-Turkey
with 7 Directs
* Responsible Person for Regulatory Requirements
(PRRC) according to Art. 15 MDR for the business unit
Cardiopulmonary
* Quality Management Representative at the
manufacturing site in Hechingen Germany, production
Disposables Cardiopulmonary
* Board Member of the management team of the
Cardiopulmonary business unit
* Quality Lead for MDR implementation
* Management of the FDA inspection preparations at the
sites in Hechingen, Bodelshausen and Rastatt -
Leading remediation program due Consent Decree
* Managing Change of the Notified Body
01/2011
-
05/2023
Head of Validation
Warner Chilcott Deutschland GmbH
* Assure the sufficient validation, qualification and
calibration at the manufacturing site Weiterstadt in
compliance with national and international regulatory
requirements
* Responsible for internal and external audits
* Cooperate in global cross functional validation teams
* Financial accountability for the validation budget
* Lead external experts and employees in the own
organization with 12 direct reports
calibration at the manufacturing site Weiterstadt in
compliance with national and international regulatory
requirements
* Responsible for internal and external audits
* Cooperate in global cross functional validation teams
* Financial accountability for the validation budget
* Lead external experts and employees in the own
organization with 12 direct reports
01/2020
-
01/2021
Director, Head of External Supply Quality Processes and
Merck Healthcare KGaA
* Organization and processes - orchestrate organizational
and process changes at global external supply quality
* Business and products evolution - Manage quality
related projects until the product enters commercial
phase or legacy products for technology transfers
* Process owner for Quality Risk Management
Process owner for Regulatory Compliance - orchestrate
the Quality Reference File process within global
operation
and process changes at global external supply quality
* Business and products evolution - Manage quality
related projects until the product enters commercial
phase or legacy products for technology transfers
* Process owner for Quality Risk Management
Process owner for Regulatory Compliance - orchestrate
the Quality Reference File process within global
operation
01/2017
-
01/2020
Director, Head of Quality Assurance Chemical and
Pharmaceutical Development
* Identify and assure implementation of relevant quality
standards, standard procedures and guidelines
* Ensure continuous improvement of quality systems
* Quality system reviews, maintenance/analysis of KPI's
* Identification and mitigation of quality risks
* Assure that the quality organization and its capabilities
are sufficient to ensure sustainable compliance in
relevant GMP area
* Direct management of inspections/audits conducted by
health authorities, global and corporate quality units
* Maintain the systems required for the efficient and
effective QP assessment and disposition of
investigational medicinal products
* Assure that vendors are acceptable for the intended
purpose and audited at defined frequencies
* Member of the development site leadership team
* Responsible for staff in the QA organization 20 directs
* Financial accountability for the quality budget
standards, standard procedures and guidelines
* Ensure continuous improvement of quality systems
* Quality system reviews, maintenance/analysis of KPI's
* Identification and mitigation of quality risks
* Assure that the quality organization and its capabilities
are sufficient to ensure sustainable compliance in
relevant GMP area
* Direct management of inspections/audits conducted by
health authorities, global and corporate quality units
* Maintain the systems required for the efficient and
effective QP assessment and disposition of
investigational medicinal products
* Assure that vendors are acceptable for the intended
purpose and audited at defined frequencies
* Member of the development site leadership team
* Responsible for staff in the QA organization 20 directs
* Financial accountability for the quality budget
01/2014
-
01/2017
Associate Director, Head of Validation / Qualification and
* Establish and update of quality standards and
implementation global quality standards
* Assessment of the GMP compliance for all validation,
qualification and engineering activities in the solid, liquid
and packaging plants on site
* Quality assurance of process validation activities during
site to site and CMO product transfers
* Support of new product launches
* Supplier audits as GMP auditor
* Management of inspections/audits conducted by health
authorities, global and corporate quality units
* Lead external experts and employees in the own
organization and in cross-functional projects
implementation global quality standards
* Assessment of the GMP compliance for all validation,
qualification and engineering activities in the solid, liquid
and packaging plants on site
* Quality assurance of process validation activities during
site to site and CMO product transfers
* Support of new product launches
* Supplier audits as GMP auditor
* Management of inspections/audits conducted by health
authorities, global and corporate quality units
* Lead external experts and employees in the own
organization and in cross-functional projects
01/2011
-
01/2014
Quality Manager, Deputy Head of Quality Planning &
Roche Diagnostics GmbH; Roche Diabetes Care AG
* Lead validation projects for manufacturing lines for
insulin pumps
* Equipment management for test- and operating
materials, equipment and IT-Systems
* Transfer of a manufacturing site from Switzerland to
Germany - process owner for process validation and
equipment management
* Lead of external consultants in validation projects
* Deputy head of the team's: process validation, quality
planning and risk management
insulin pumps
* Equipment management for test- and operating
materials, equipment and IT-Systems
* Transfer of a manufacturing site from Switzerland to
Germany - process owner for process validation and
equipment management
* Lead of external consultants in validation projects
* Deputy head of the team's: process validation, quality
planning and risk management
01/2010
-
01/2011
Senior Project Engineer
M+W Process Industries GmbH
* Lead cleaning validation projects in biopharmaceutical
industry
* Business development - Establishing a new cleaning
validation service for the pharmaceutical industry
* Cooperate with global cross functional and cultural
engineering and validation teams - Building of a new
manufacturing site for vaccines
industry
* Business development - Establishing a new cleaning
validation service for the pharmaceutical industry
* Cooperate with global cross functional and cultural
engineering and validation teams - Building of a new
manufacturing site for vaccines
01/2007
-
01/2010
Validation Engineer
Boehringer Ingelheim Pharma GmbH & Co. KG
* Validation of the cleaning and transport processes at
the manufacturing site in Ingelheim for solid products
* Develop new cleaning processes and transfer to
commercial manufacturing area
* Develop shipment simulations (cycling studies) for
transport validation projects
* Support manufacturing of IMPs for clinical studies and
launch of new products
* Technology/process transfer from site to site
the manufacturing site in Ingelheim for solid products
* Develop new cleaning processes and transfer to
commercial manufacturing area
* Develop shipment simulations (cycling studies) for
transport validation projects
* Support manufacturing of IMPs for clinical studies and
launch of new products
* Technology/process transfer from site to site
Reisebereitschaft
Verfügbar in den Ländern
Schweiz
