Timur Güvercinci

Senior Quality Project Expert and Consultant in the Pharmaceutical Industry

Timur Güvercinci
Ludwigshafen am Rhein, Germany

Experience

Jan 2023 - Dec 2024
2 years
Ludwigshafen, Germany

Senior Quality Project Expert and Consultant in the Pharmaceutical Industry

Self-Employed Consultant

  • Worked with Sanofi Aventis Frankfurt/Höchst site on manufacturing of large molecules, improving QMS processes and quality optimization projects for operations
  • Led a cleaning development and validation project under CFR 21/EU GMP Regulation at MSD Vet Pharma Friesoythe GmbH site for veterinary medicinal products
  • Served as expert for CSV, process validation and equipment qualification system validation projects at Roche Diagnostics Deutschland GmbH Mannheim site
  • Provided GMP consulting to a small IT company for development of a cloud-based documentation management system for large molecules in the pharmaceutical industry
  • Provided GMP consulting to a large IT company for development of software for continued process verification of solid and liquid sterile products
Jan 2021 - Dec 2023
3 years

Senior Director, Head of Quality Cardiopulmonary - Active and Non-Active Medical Devices

Getinge AB

  • Managed quality organization Cardiopulmonary with 170 employees at sites in Germany and Turkey with seven direct reports
  • Developed individual development plans for direct reports covering soft skills (Big 5 model) and hard skills based on gap analysis
  • Led Regulatory Affairs department per dotted line with one direct report and 20 headcount
  • Executed major QMS remediation program after FDA consent decree, including CAPA and complaint management system improvements
  • Harmonized global QMS system across all local sites
  • Prepared for FDA inspections at three German sites using a self-developed training program on communication and behavior
  • Acted as Responsible Person for Regulatory Requirements (PRRC) according to Art. 15 MDR for Cardiopulmonary business unit
  • Served as Quality Management Representative at Hechingen manufacturing site for disposables Cardiopulmonary
  • Served as board member of the Cardiopulmonary business unit management team
  • Led MDR implementation and managed change to a new Notified Body
Jan 2020 - Dec 2021
2 years
Darmstadt, Germany

Director, Head of External Supply Quality Processes and Development - Global Quality

Merck Healthcare KGaA

  • Improved global QMS for external supplier and CMO management by integrating a new Quality Risk Management process
  • Created a harmonized quality compliance file process across EMEA sites working with CMOs and built a new global regulatory compliance team
  • Implemented project management tools into global CMO Quality Management System to structure and drive QA processes efficiently
  • Managed quality-related projects until products entered commercial phase or for legacy product technology transfers
Jan 2017 - Dec 2020
4 years
Darmstadt, Germany

Director, Head of Quality Assurance Chemical and Pharmaceutical Development

Merck Healthcare KGaA

  • Adapted QMS into pharmaceutical development processes including CDMO qualification, analytical method development, manufacturing process development, investigational medicinal product manufacturing and clinical trials supply
  • Conducted quality system reviews and maintained KPI analysis for deviations, investigations, CAPAs, change implementations, supplier/CMO qualification and audit efficiency
  • Improved application of Quality by Design by linking process and material impact to product efficiency and safety using risk management tools
  • Developed and led Qualified Persons, Quality Managers and Quality Technicians with individual development plans
  • Harmonized global QMS between manufacturing sites in Germany, Italy and France
  • Managed inspections and audits by health authorities, global and corporate quality units
  • Maintained systems for efficient QP assessment and disposition of investigational medicinal products
  • Ensured vendor acceptability and audits at defined frequencies
  • Served on development site leadership team with financial accountability for quality budget
Jan 2014 - Dec 2017
4 years
Darmstadt, Germany

Associate Director, Head of Validation/Qualification and Engineering

Merck Healthcare KGaA

  • Led and developed senior managers for CSV, process and cleaning validation and equipment qualification
  • Integrated new FDA process validation approach, lifecycle related cleaning validation process and periodic review process for validated processes into local QMS
  • Implemented a semi-automated continued process verification IT system and computerized system validation
  • Established and updated global quality standards for CSV, process validation, cleaning validation and equipment qualification
  • Led PAI preparation project according to CAPA plan to eliminate QMS gaps in development, transfer and validation
  • Assessed GMP compliance for CSV, process validation, cleaning validation, equipment qualification and engineering activities across solid, liquid and packaging plants
  • Provided quality assurance for process validation during site-to-site and CMO product transfers
  • Supported new product launches and performed supplier audits as GMP auditor
  • Managed inspections and audits by health authorities, global and corporate quality units
Jan 2011 - Dec 2014
4 years

Quality Manager, Deputy Head of Quality Planning & Validation

Roche Diagnostics GmbH; Roche Diabetes Care AG

  • Executed computerized system validation and process validation projects for insulin pump manufacturing
  • Managed equipment for test and operating materials, equipment and IT systems
  • Owned process validation and equipment management during transfer of manufacturing site from Switzerland to Germany
  • Led external consultants in validation projects
  • Served as deputy head of process validation, quality planning and risk management teams
Jan 2011 - Dec 2011
1 year

Head of Validation

Warner Chilcott Deutschland GmbH

  • Led a team of 12 experts executing computerized system validation, cleaning validation, equipment qualification and calibration of facility and systems
  • Responsible for internal and external audits
  • Collaborated in global cross-functional validation teams
  • Managed validation budget
Jan 2010 - Dec 2011
2 years
Ludwigshafen, Germany

Senior Project Engineer

M+W Process Industries GmbH

  • Led cleaning validation projects in the biopharmaceutical industry
  • Developed business by establishing a new cleaning validation service for the pharmaceutical industry
  • Collaborated with global cross-functional and cultural engineering and validation teams to build a new vaccine manufacturing site
Jan 2007 - Dec 2010
4 years
Ingelheim am Rhein, Germany

Validation Engineer

Boehringer Ingelheim Pharma GmbH & Co. KG

  • Validated cleaning and transport processes for solid product manufacturing
  • Developed new cleaning processes and transferred them to commercial manufacturing areas
  • Designed shipment simulations (cycling studies) for transport validation projects
  • Supported manufacturing of investigational medicinal products for clinical studies and new product launches
  • Managed technology and process transfers site to site

Summary

Experienced quality leader with 17 years of professional experience in the pharmaceutical and medical device industries. Lead various projects and teams with increasing responsibility. Deep end-to-end knowledge in processes and the regulatory requirements from Timur Güvercinci development to commercialization of pharmaceuticals and Medical Devices. Experience in building and restructuring organizations. Freelance lecturer at TÜV Süd Academy and international events and congresses.

Skills

Soft-skills

  • Personal Competence: Emotional Intelligence, Self-reflection, Self-confidence
  • Social Competence: Appreciation, Intercultural Competence, Persuasion
  • Methodical Competence: Structured And Solution Oriented, Analytical Capability, Problem Solving Competence, Resistance To Stress

Computer-skills

  • Microsoft
  • Track Wise
  • Sap
  • Cara Mango
  • Pas/x-mes

Languages

German
Native
English
Advanced
Turkish
Advanced

Education

Oct 2020 - Present

Medical Faculty Mannheim, Heidelberg University

Human Medicine · Mannheim, Germany

Oct 2003 - Jun 2007

University of Albstadt-Sigmaringen

Graduate Engineer Pharmaceutical Engineering, Operating Technology · Pharmaceutical Engineering · Germany

Oct 1999 - Jun 2002

University of Furtwangen

Medical Engineering · Furtwangen, Germany

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