Omer Cimen

Omer Cimen Email and Phone Number

Co-Founder and CEO @ Validfor
Estonia
Omer Cimen's Location
Istanbul, Türkiye, Turkey
Omer Cimen's Contact Details

Omer Cimen work email

Omer Cimen personal email

n/a
About Omer Cimen

With 17 years of experience in Pharma, I led numerous high-impact projects for global pharmaceutical and healthcare clients such as Novartis, Mundipharma, Sandoz and others. My experience spans across SAP and S4HANA implementations, where I played critical roles, from Project Quality Manager to Validation Lead. I managed rollouts in diverse locations, including the UK, Turkey, Japan, India, Poland, North Macedonia, Bangladesh, Egypt, Germany, Austria, Slovenia and Switzerland, ensuring compliance with GMP, GAMP, and 21 CFR Part 11. My expertise includes risk assessments, project management, and software/system validation life cycle management. Now, I am the founder of Validfor, a cutting-edge software validation life cycle management solution. At Validfor, we aim to streamline and enhance the software validation process for companies, helping them achieve compliance and operational excellence. I am passionate about leveraging my experience to deliver innovative and efficient solutions that drive business growth and digital transformation.

Omer Cimen's Current Company Details
Validfor

Validfor

View
Co-Founder and CEO
Estonia
Website:
validfor.com
Employees:
2
Omer Cimen Work Experience Details
  • Validfor
    Co-Founder And Ceo
    Validfor
    Estonia
  • Validfor
    Founder
    Validfor Oct 2024 - Present
  • Mundipharma
    Programme Validation Stream Lead
    Mundipharma Mar 2021 - Sep 2024
    United Kingdom
    Delivered agile validation support across diverse systems, including equipment, computerized systems, in a complex, multi-disciplinary validation program. Enhanced project agility and streamlined processes through continuous quality monitoring.
  • Conval Group
    Head Of Business Development
    Conval Group Nov 2007 - Sep 2024
    Istanbul, Turkey
    During my 17-year tenure at Conval, I played a key role in driving the company’s growth through various complex and large-scale projects. I specialized in developing comprehensive validation strategies tailored to customer needs and led a team that managed over 20+ major and 90+ small/medium-sized projects. My responsibilities included mentoring junior consultants, managing customer success, and spearheading digital transformation efforts. Additionally, I established and expanded the digital services department, significantly enhancing Conval's capability to deliver efficient and innovative solutions.
  • Novartis
    Programme Quality Manager
    Novartis Dec 2017 - Aug 2021
    Switzerland
    Directed validation strategy across multiple streams for an extensive program initiative. Applied agile methodologies to coordinate validation efforts across systems, ensuring consistent compliance with quality and regulatory requirements.
  • Novartis
    Programme Quality Manager
    Novartis Oct 2015 - Dec 2017
    Slovenia
    Led quality management for a project to enhance and rebuild advanced planning processes. Ensured compliance and validation throughout the transformation, optimizing planning workflows for efficiency and alignment with quality standards.
  • Novartis
    Project Quality Manager
    Novartis Jan 2015 - Aug 2015
    Switzerland
    Provided quality assurance and validation support for the SAP system, specializing in CSV processes to ensure robust compliance and seamless project alignment across cross-functional teams.
  • Novartis
    Project Quality Manager
    Novartis Aug 2014 - May 2015
    Austria
    Led quality management and validation for a greenfield ERP implementation at a new manufacturing facility. Established comprehensive validation protocols to ensure quality and regulatory compliance from project initiation to operational readiness.
  • Novartis
    Project Quality Manager
    Novartis Sep 2013 - Jun 2014
    Japan
    Pioneered a paperless testing framework for validation, later adopted by the client as an internal standard for efficiency and compliance. Championed digital transformation in quality processes, achieving substantial improvements in validation speed and accuracy.
  • Sandoz
    Project Quality Manager
    Sandoz Feb 2013 - Sep 2013
    Germany
    Collaborated with global teams to lead Computerized System Validation (CSV) initiatives. Focused on maintaining compliance across CSV projects within a structured quality framework.
  • Sandoz
    Project Quality Manager
    Sandoz Jul 2012 - Feb 2013
    Egypt
    Engineered innovative solutions to overcome project challenges in emerging markets. Spearheaded digital approval workflows to streamline project processes.
  • Sandoz
    Project Quality Manager
    Sandoz Feb 2012 - Jul 2012
    Bangladesh
    Developed and adapted validation methodologies for geographically dispersed teams, facilitating collaboration across multiple locations. Implemented hybrid solutions for cohesive project execution.
  • Turkish Airlines
    Project Quality Manager
    Turkish Airlines Mar 2011 - Oct 2012
    Türkiye
    Oversaw SAP implementation within the aviation sector, emphasizing quality controls and project methodology. Maintained high standards of project governance and validation integrity.
  • Lek Pharmaceuticals
    Project Quality Manager
    Lek Pharmaceuticals Oct 2011 - Feb 2012
    North Macedonia
    Led quality assurance for an ERP validation project, serving as the hub for multiple nearby countries. Managed cross-border compliance, ensuring the project's adherence to quality standards and harmonized procedures across regional hubs.
  • Sandoz
    Validation Consultant
    Sandoz Apr 2010 - Feb 2011
    India
    Directed the validation process for ERP deployment across three manufacturing sites. Coordinated cross-functional teams to manage change control, test execution, and deviation resolution for comprehensive ERP coverage.
  • Sandoz
    Validation Consultant
    Sandoz Apr 2009 - Feb 2010
    Germany
    Provided validation expertise for SAP implementation. Specialized in risk assessment, change management, and test validation for enhanced system reliability.
  • Lek Pharmaceuticals
    Validation Consultant
    Lek Pharmaceuticals Jul 2008 - Feb 2009
    Poland
    Executed validation activities for a full-scale ERP deployment, addressing requirements across multi-site manufacturing facilities. Focused on change management and testing to ensure compliance and seamless operational integration.
  • Sandoz
    Validation Consultant
    Sandoz Nov 2007 - Jul 2008
    Türkiye
    ERP implementation validation for manufacturing, quality, and supply chain functions across two manufacturing sites. Oversaw all aspects of validation, including change management, test case development, and deviation handling.

Omer Cimen Education Details

Frequently Asked Questions about Omer Cimen

What company does Omer Cimen work for?

Omer Cimen works for Validfor

What is Omer Cimen's role at the current company?

Omer Cimen's current role is Co-Founder and CEO.

What is Omer Cimen's email address?

Omer Cimen's email address is om****@****for.com

What schools did Omer Cimen attend?

Omer Cimen attended Istanbul University.

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