Digitalization of Quality Processes & Dashboard Design
Turkish
Muttersprache
English
Fortgeschritten
German
Muttersprache
Einsatzorte
Einsatzorte
Deutschland, Schweiz, Österreich
möglich
Projekte
Projekte
1 Monat
2025-12 - heute
Quality Risk Management
Freelance Quality Consultant
Freelance Quality Consultant
Quality Risk Management
Supplier Quality Management
Audit Management (GMP, ISO 9001)
Quality Management System design & improvement
Veeva Vault IT System implementation & validation
4 Jahre 3 Monate
2021-09 - 2025-11
Quality Risk Management
Associate Director
Associate Director
Lead Enterprise and Quality Risk Management (ERM & QRM) for Corporate Quality, ensuring consistent application of ICH Q9 principles
Designed and implemented enhanced QRM frameworks to strengthen risk visibility and mitigation tracking at corporate and site level
Partnered with leadership to review and endorse global risk portfolio, emerging trends, and mitigation performance indicators
Spearheaded development of a QRM digitalization initiative, piloted across 4 strategic manufacturing sites to standardize risk methodology
Designed and implemented global QRM IT System in Veeva Vault
Authored governance materials, dashboards, and senior-level reports for the Chief Quality Officer and Quality Leadership Team
Coached risk owners and local quality teams to improve maturity and consistency in risk evaluation practices
Bayer AG
Leverkusen, Germany
3 Jahre 2 Monate
2018-07 - 2021-08
Deviation Management
Global Quality Process Manager
Global Quality Process Manager
Bayer AG
Leverkusen, Germany
2 Jahre
2016-07 - 2018-06
Represented Supplier Management & Audit function
Quality Manager, Supplier Management & Audit
Quality Manager, Supplier Management & Audit
Deputy Head of Supplier Management & Audit
Performed supplier, service provider and drug product manufacturer audits (GxP & ISO 9001)
Represented Supplier Management & Audit function at health authority & customer inspections
Reviewed PQRs, deviations, OOS results, stability data, QC performance, audit outcomes, and Quality Assurance Agreements for annual supplier evaluation and approval
Led supplier performance evaluations, ensuring partners met GxP expectations and providing key inputs for Quality oversight
Negotiated Quality Assurance Agreements with suppliers
Established standardized supplier and service provider approach
Investigated supplier-related deviations and coordinated CAPAs to ensure supply of products and product quality
Bayer AG
Leverkusen, Germany
2 Jahre 8 Monate
2013-11 - 2016-06
Qualified suppliers for biotech and pharmaceutical manufacturing components
Site Quality Specialist, Supplier Qualification
Site Quality Specialist, Supplier Qualification
Qualified suppliers for biotech and pharmaceutical manufacturing components, reviewing technical and GMP documentation to ensure material readiness for compliant drug product manufacturing
Identified of new or alternative suppliers
Managed complaints from market
Led Materials Management project for transfer of biotech product
Participated in supplier audits and health authority & customer inspections
Bayer AG
Leverkusen, Germany
6 Monate
2013-05 - 2013-10
Intern, Business Continuity Management
Supported global rollout of FDA guidance for industry on Business Continuity Planning for drug product availability in case of high employee absenteeism
Developed a global standard for business continuity management integrated across multiple GMP site
Bayer AG
Leverkusen, Germany
Aus- und Weiterbildung
Aus- und Weiterbildung
5 Jahre 1 Monat
2007-05 - 2012-05
Pharmazie
Master of Pharmacy (State Examination), Heinrich-Heine-Universität Düsseldorf
Quality and Risk Management professional with over 12 years of experience in the pharmaceutical industry, specializing in the design, deployment, and continuous improvement of Quality Management Systems across global GxP environments
Experience in GMP operations, specializing in manufacturing quality oversight, GxP compliance, auditing and supplier management
Lead Enterprise and Quality Risk Management (ERM & QRM) for Corporate Quality, ensuring consistent application of ICH Q9 principles
Designed and implemented enhanced QRM frameworks to strengthen risk visibility and mitigation tracking at corporate and site level
Partnered with leadership to review and endorse global risk portfolio, emerging trends, and mitigation performance indicators
Spearheaded development of a QRM digitalization initiative, piloted across 4 strategic manufacturing sites to standardize risk methodology
Designed and implemented global QRM IT System in Veeva Vault
Authored governance materials, dashboards, and senior-level reports for the Chief Quality Officer and Quality Leadership Team
Coached risk owners and local quality teams to improve maturity and consistency in risk evaluation practices
Bayer AG
Leverkusen, Germany
3 Jahre 2 Monate
2018-07 - 2021-08
Deviation Management
Global Quality Process Manager
Global Quality Process Manager
Bayer AG
Leverkusen, Germany
2 Jahre
2016-07 - 2018-06
Represented Supplier Management & Audit function
Quality Manager, Supplier Management & Audit
Quality Manager, Supplier Management & Audit
Deputy Head of Supplier Management & Audit
Performed supplier, service provider and drug product manufacturer audits (GxP & ISO 9001)
Represented Supplier Management & Audit function at health authority & customer inspections
Reviewed PQRs, deviations, OOS results, stability data, QC performance, audit outcomes, and Quality Assurance Agreements for annual supplier evaluation and approval
Led supplier performance evaluations, ensuring partners met GxP expectations and providing key inputs for Quality oversight
Negotiated Quality Assurance Agreements with suppliers
Established standardized supplier and service provider approach
Investigated supplier-related deviations and coordinated CAPAs to ensure supply of products and product quality
Bayer AG
Leverkusen, Germany
2 Jahre 8 Monate
2013-11 - 2016-06
Qualified suppliers for biotech and pharmaceutical manufacturing components
Site Quality Specialist, Supplier Qualification
Site Quality Specialist, Supplier Qualification
Qualified suppliers for biotech and pharmaceutical manufacturing components, reviewing technical and GMP documentation to ensure material readiness for compliant drug product manufacturing
Identified of new or alternative suppliers
Managed complaints from market
Led Materials Management project for transfer of biotech product
Participated in supplier audits and health authority & customer inspections
Bayer AG
Leverkusen, Germany
6 Monate
2013-05 - 2013-10
Intern, Business Continuity Management
Supported global rollout of FDA guidance for industry on Business Continuity Planning for drug product availability in case of high employee absenteeism
Developed a global standard for business continuity management integrated across multiple GMP site
Bayer AG
Leverkusen, Germany
Aus- und Weiterbildung
Aus- und Weiterbildung
5 Jahre 1 Monat
2007-05 - 2012-05
Pharmazie
Master of Pharmacy (State Examination), Heinrich-Heine-Universität Düsseldorf
Quality and Risk Management professional with over 12 years of experience in the pharmaceutical industry, specializing in the design, deployment, and continuous improvement of Quality Management Systems across global GxP environments
Experience in GMP operations, specializing in manufacturing quality oversight, GxP compliance, auditing and supplier management