Discover the PCG Difference!
Now Hiring: Senior QA Manager
PCG Clinical Services AB is a CRO with the head office located in Uppsala. The company started in 2003 and has expanded steadily since its inception; Today we are about 60 people. PCG Clinical Services offers full CRO services including project management, data management, biostatistics, medical writing and monitoring. Our proprietary EDC system, Viedoc ™, is used in studies worldwide.
Senior QA Manager
We are looking for an experienced Senior QA Manager who will be responsible for our QA department.
The Senior QA Manager conducts necessary audits and trainings to ensure compliance runs smoothly throughout operations and that clinical trials are performed in accordance with applicable study protocols and in compliance with regulations, guidelines and PCG processes and procedures. The Senior QA Manager ensures that the appropriate quality system is in place.
You have previous experience from work within clinical trials from the pharmaceutical industry, CRO, or similar business and have a university education in science / medicine. Doctoral title is meritorious. You have several years of experience as a QA Manager with overall quality responsibility. At present, our QA department consists only of this position, which means that the work is varied and that you must be both operational and communicative while at the same time having overall control over the company's quality as well as all relevant regulations. As a large number of our customers are international and all documentation is in English, very good knowledge in both Swedish and English, written and spoken, is a requirement.
You have excellent knowledge of ICH-GCP, ISO14155, PuL and other current and relevant regulations and standards and possess a thorough understanding of strategic and operational aspects within clinical research and development.
As a person, you are flexible, structured, accurate and communicative and have a passionate interest in quality.
If you would like to know more about the position, please contact: