Clintec has an exciting opportunity for a Senior Quality Specialist/Quality Project Manager to lead our pharmaceutical client's QMS redesign project. Previous Quality experience within a GMP enivronment is required. Apply now to become part of our global CRO.
Senior Quality Specialist (GMP)
Senior Quality Specialist (GMP) - Permanent - near Lucerne
Clintec is currently looking to hire a Senior Quality Specialist to join our growing team in Switzerland. The Senior Quality Specialist will work directly in-sourced to our global pharmaceutical client from their state of the art facility near Lucerne, Switzerland.
The Senior Quality Specialist will lead a project for our client, notably the introduction and redesign of their QMS (Quality Management System). The redesign of the QMS is divided into several ‘Chapters’, with the successful applicant being responsible for the overall project. They will deliver input to the global project team from the Swiss site and be in close contact with both the internal stakeholders on site and the global project team.
Responsible for coordinating and leading the implementation of the new Clinical Supply Quality Management Standards (QMS) at the Swiss site.
Key collaborator working closely with site personnel and Global Clinical Supply QMS Redesign Team to ensure successful implementation of new QMS at the Swiss site
Perform documentation review to ensure consistency (e.g. language, formatting, etc. ) within the Redesign Team and across the Clinical Supply network
Serve as communication channel between Swiss site personnel and US site personnel
Assist the facilitation of mock evaluations (i.e. simulations) and site-based pilots conducted at the site
Assist with site metrics collection / reporting and sharing of success stories / achievements
Support other Quality Assurance members when necessary
Experience in regulated environment, preferably within GMP
Minimum of 3-5 years of experience within Quality Assurance
Experience and expert knowledge of QA and Quality Management Systems
Ideally previous Project Management experience
Excellent communication and negotiation skills
Fluency in German and English.
We are looking for someone to start ASAP, ideally the start of May.
Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.
Mr Adam Davis
Senior Global Resourcing Executive
133 Finnieston Street