Hakan Terzi

Quality leadership, overseeing internal/external audits, validation projects, CAPAs, training & adoption in the area of clinical trials tech service. QMS governance towards GxP for operational excellence. Ownership of QA function including management of Auditing Services. Responsible for regulatory inspections, internal & vendor auditing program. Being ambassador for quality promoting company's quality standards, compliance & inspection readiness incl. customer & vendor relationship contractual obligations.

Governing Calyx QMS, leading and overseeing Calyx’s Auditing Services function, providing leadership & quality expertise towards industry standards & GxP regulations, engaging in sponsor audits & regulatory inspections and representation of Calyx Quality & Compliance for client and vendor contract negotiations and its obligations.

Provides leadership, strategic/tactical planning within technology quality managing teams worldwide. Represents the organization in inspection and conducts internal audits. Drives adoption/continuous improvement of quality towards CTQC ensuring FTQ with a ZDMS avoiding CONQ. As ambassador for Quality within the wider organization promoting the quality framework providing inspection readiness towards GxP compliance & industry standards.

As a Senior Manager within PAREXEL, provides strategic/tactical planning within the Technology Quality department heading the US&EU teams. As the Audit Lead, chairs the worldwide Technology Quality audit team and represents PAREXEL in key audits/inspection worldwide, especially in preferred partnerships. Oversees the company’s Technology Quality framework. As ambassador for Quality within the wider organization promoting Technology Quality principles and representing PAREXEL infront of major clients.

Chairing the worldwide audit team, representing PAREXEL in internal/external audits/inspection worldwide, Performing vendor audits for PAREXEL. Overseeing company’s validation framework, its maintenance and transfer into operations, including training. Supporting CSV projects from a Quality Management perspective including validation management and consultancy. Coaching, mentoring and training of colleagues to validation/quality principles for CSV.

IT Qualitäts-, Projekt-, Configuration Management, Object Orientierte Softwareentwicklung (OOA, OOD, OOI)

Analyse, Design und Implementierung (UML) im terra3d projekt, Anwendungs-Programmierung mit MS-Visual Studio und KDevelop, Linux-Windows Server und Desktop Administrator, Skript- und Shell Programmierung in C/C++

Softwaretechnik (Software Engineering)