Timur Güvercinci - Senior Quality Project Expert and Consultant in the Pharmaceutical Industry

Q: Where is Timur based?

Timur is based in Ludwigshafen am Rhein, Germany and can operate in on-site , hybrid , and remote work models.

Q: What languages does Timur speak?

Timur speaks the following languages: German (Native), English (Advanced), Turkish (Advanced) .

Q: How many years of experience does Timur have?

Timur has at least 18 years of experience. During this time, Timur has worked in at least 9 different roles and for 7 different companies . The average length of individual experience is 2 years . Note that Timur may not have shared all experience and actually has more experience.

Q: What is Timur's latest experience?

Timur's most recent position is Senior Quality Project Expert and Consultant in the Pharmaceutical Industry at Self-Employed Consultant .

Q: What companies has Timur worked for in recent years?

In recent years, Timur has worked for Self-Employed Consultant , Getinge AB , and Merck Healthcare KGaA .

Q: Which industries is Timur most experienced in?

Timur is most experienced in industries like Pharmaceutical , Healthcare , and Biotechnology .

Q: Which business areas is Timur most experienced in?

Timur is most experienced in business areas like Quality Assurance (QA) , Operations , and Project Management . Timur also has some experience in Product Development and Production/Manufacturing .

Q: Which industries has Timur worked in recently?

Timur has recently worked in industries like Pharmaceutical and Healthcare .

Q: Which business areas has Timur worked in recently?

Timur has recently worked in business areas like Quality Assurance (QA) , Project Management , and Operations .

Recommended expert

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

Industries Experience

See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.

Experienced in Pharmaceutical (17 years), Healthcare (7 years), and Biotechnology (2 years).

Pharmaceutical

Healthcare

Biotechnology

Business Areas Experience

The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.

Experienced in Quality Assurance (18 years), Operations (6 years), Project Management (6 years), Product Development (4 years), and Production (4 years).

Quality Assurance

Operations

Project Management

Product Development

Production

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

Profile

Created

April 2025

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Timur based?

Timur is based in Ludwigshafen am Rhein, Germany and can operate in on-site, hybrid, and remote work models.

What languages does Timur speak?

Timur speaks the following languages: German (Native), English (Advanced), Turkish (Advanced).

How many years of experience does Timur have?

Timur has at least 18 years of experience. During this time, Timur has worked in at least 9 different roles and for 7 different companies. The average length of individual experience is 2 years. Note that Timur may not have shared all experience and actually has more experience.

What roles would Timur be best suited for?

Based on recent experience, Timur would be well-suited for roles such as: Senior Quality Project Expert and Consultant in the Pharmaceutical Industry, Senior Director, Head of Quality Cardiopulmonary - Active and Non-Active Medical Devices, Director, Head of External Supply Quality Processes and Development - Global Quality.

What is Timur's latest experience?

Timur's most recent position is Senior Quality Project Expert and Consultant in the Pharmaceutical Industry at Self-Employed Consultant.

What companies has Timur worked for in recent years?

In recent years, Timur has worked for Self-Employed Consultant, Getinge AB, and Merck Healthcare KGaA.

Which industries is Timur most experienced in?

Timur is most experienced in industries like Pharmaceutical, Healthcare, and Biotechnology.

Which business areas is Timur most experienced in?

Timur is most experienced in business areas like Quality Assurance (QA), Operations, and Project Management. Timur also has some experience in Product Development and Production/Manufacturing.

Which industries has Timur worked in recently?

Timur has recently worked in industries like Pharmaceutical and Healthcare.

Which business areas has Timur worked in recently?

Timur has recently worked in business areas like Quality Assurance (QA), Project Management, and Operations.

What is Timur's education?

Timur holds a Bachelor in Pharmaceutical Engineering from University of Albstadt-Sigmaringen and a Bachelor in Medical Engineering from University of Furtwangen.

What is the availability of Timur?

Timur is immediately available part-time for suitable projects.

What is the rate of Timur?

Timur's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.