Quality Manager GcP within Pharma Research Job in Basel (Ch)
At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.
The headquarters in Basel is one of Roche’s largest sites, over 8,000 people from approximately 80 countries work at Roche Basel. Favored by its geographic location in the heart of Europe, the Basel area is one of the most dynamic economic regions in Switzerland – a great place to live and work.
pREDi is an informatics organization supporting research and early development in Roche Pharma. This organization is responsible for supporting applications that are governed by GCP regulations. Computer system validation is an integral part of our business. In this context we are looking to further improve our capability to deliver validated IT systems and maintain them in a validated state. To assist in this endeavor we are looking for a GCP Quality Manager to support this area. The position will be based in Basel and will be part of the pREDi Quality team and focusing on global systems used in the context of clinical trials working closely together with the Early Development Informatics domain.
This position will be involved in the compliance of GCP regulated computerised systems to:
- Implement quality procedures for the development and operation of computerised systems
- Review/Approve risk assessment and control activities
- Support project phase activities as defined in computerized system validation plans
- Support lifecycle processes such as change control and document management
- Provide training related to computerised systems quality and compliance
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.
- Master’s degree or equivalent and 5+ years of experience in computer system validation preferably in the GCP area
- 5+ years of experience in an international corporation, preferentially in Pharmaceutical Industry
- Experienced in FDA regulations, 21 CFR Part 11, GCP guidelines
- Experience in information technology
- Some travel required (2-4 trips per year - international travel)
- Background in quality assurance, participation on global teams, and/or project management experience
- Detail oriented, structured thinking
- Excellent writing skills in English
- Excellent communication skills
- Ability to influence
- Ability to work in different cultures
The next step is yours. To apply today, click on the "Apply online" button below.
Roche is an Equal Opportunity Employer
We are currently not able to send an email confirmation once you have completed your application. Please ensure you click “submit” on the summary page of the application process!
