Fribourg, Fribourg, Switzerland
Pierre-Alain CHRISTOPHE has 20 years of experience in pharmaceutical and chemical industries and has more than 10 years of functional management experience. He has extensive experience in developing and managing ISO and FDA compliant quality systems. Pierre-Alain has worked for global companies such as Amersham Pharmacia and Wyeth. His next objective is to hold a global position in Quality management. Specialties: GMP regulations; validation; FDA inspection; team management; electronic document management; Computer systems; Microbiology; environmental monitoring; clean rooms; DNA sequencing; PCR;
Serving as the primary contact for all affiliate QA activities within the region. Providing oversight, direction and support for the implementation and enhancement of quality systems at affiliate sites. Assisting affiliate QA resources in the qualification and on-going monitoring of quality-key 3rd party suppliers. Working with site management at the affiliates to ensure that their QA systems are properly resourced, trained and maintained. Leading the implementation of the Novartis Quality Manual for affiliates in the region.
Implemented Corporate Quality strategy and policies on all seed sites in the EMEA (Europe, Middle-East & Africa) region. Coordinated centrally with site and quality managers in EAME for Quality Management implementation and ISO certifications. Participated in the Corporate Internal Audit Program. Collaborated with Regulatory Affairs for specific product authorizations. Represented Quality in new projects within EAME.
Led and managed the Quality Assurance department. Implemented Quality Systems following ISO 9001:2008. Managed internal and external audits. Supervised customer complaints management. Implemented an Integrated management System (IMS). Represented Quality in all Lean activities. Developed and implemented all Quality systems.
Responsible for the management of Quality Assurance and Quality Control.
Managed quality aspects during the start-up of the site including validation. Created and headed the Quality Records Management Team. Implemented business tools for records management. Represented the company in the area of records management during audits (EMEA, FDA).