Gürkan Budak

WORK HISTORY

EDUCATION

SKILLS

ABOUT GÜRKAN BUDAK

I am a Bachelor of Science in Computer Engineering with 15+ years of experience in SW development and a Senior Project Manager with 12+ years of project delivery records. Early in my career, I developed software solutions mainly for banking industry in the field of business process management. Back in 2009, I have developed an eQMS (electronic Quality Management System) for GMP regulated industries, which is currently one of the most widely used QMS solutions in the region. This software has been implemented for approx. 50 largest pharmaceutical companies including global and local life science leaders such as Abbott Turkey, Gensenta (Amgen Turkey), Bayer Turkey, Abdi İbrahim, Nobel, Bilim and Pharmactive.I have established and managed the PMO (Project Management Office) of my former company to perform following roles and responsibilities:• Business strategy identification and alignment• Project management• Developing procedures, tools and templates• Business relationship management• Process analysis and improvement• CSV: Documentation and execution• Client on boarding activities including training• Overseeing ELS (Early Life Support) activities• Pre-Sales activities: Delivering product demos and workshops• Partner enablementI am a self-starter with entrepreneur mind-set who always focuses on customer engagement, business relationship management, value delivery and process improvement & control. I have worked and managed projects in several countries including Germany, Austria, the USA and Turkey and delivered product demos and workshops in many more. Through those unique experiences, I have learned how enriching diversity is! I have deep knowledge on SDLC (Software Development Life Cycle), CSV (Computerized Systems Validation), QMS Processes, Quality Risk Management and Data Integrity and GMP related regulations and guidelines such as 21 CFR Part 11, EU GMP Annex 11 and ISPE GAMP 5. Over the years I have worked on the frontline side by side with various stakeholders in order to expand and deepen my processes knowledge and embraced the recent developments in my area of expertise in order to keep myself up-to-date. I am a lifelong learner and a continuous improvement enthusiastic. The certificates that I have acquired have been selected purposefully to strengthen my career in IT industry. I am an active PMP, ASQ CSSGB, ITIL v4 Managing Professional and PSM I.