You will be responsible for Quality Systems & Computer Systems Compliance activities applicable to European Union & country specific regulations & standards (ISO, SFDA) and as appropriate to best business practices (AAMI, ISO, GAMP 5). This includes managing Quality Systems Compliance Auditors & Computer Systems Compliance Specialists whilst auditing, monitoring, advising and consulting on quality and computer systems across multiple sites.
You will be in charge of maintaining and monitoring compliance to company policies for quality & computer systems compliance. You will assist in the identification and establishment of the procedures, tools and methodologies to cover all systems activities. You advise and consult within the company and with suppliers to facilitate timely resolution of quality & computer systems compliance issues and consult on company-wide projects including preproduction, production & post-production activities. You will also be responsible for partnering with PD & Operations to ensure alignment and consistent application of quality and computer systems procedures and methodology.
Your profile. You have a university or college degree with at least five years experience in a similar role with direct experience working in supervising quality and/or computer systems compliance activities in a medical device or pharmaceutical company. Experience in managing and in performing audits in an FDA or similarly regulated environment or in a notified body environment associated with medical devices or pharmaceuticals will be considered an important asset. Excellent organisational, communication, and peoples management skills are essential. Fluent oral and written skills in German and English as well as the willingness to travel are required.
For more information on this vacancy, or any other medical device opportunities, please contact the Senior Consultant Andrew Boroky on 0044 (0) 207 940 2116, or email him at firstname.lastname@example.org