- Are you passionate about working with clinical studies in an international environment, then we have an open position as Quality Manager (QM) in Clinical Study Management at our company.
- Our department is responsible for planning, managing and coordinating international clinical phase II-IV studies as well as conduct of non-interventional studies.
- In total we are 26 employees located globally and we perform clinical studies in more than 50 countries worldwide.
- We are looking for a Quality Manager (QM) to contribute to sponsor oversight of company's interventional clinical studies (phase II and onwards).
- The Quality Oversight Team contributes to ensure high quality of company’s clinical studies and to ensure oversight with respect to compliance with ICH-GCP guidelines, regulatory requirements, corporate SOPs, the study protocols and other study specific procedures – both by remote quality oversight as well as by conducting Sponsor Visits to investigational sites participating in the company's clinical studies.
- You will also be involved in following up on audit CAPAs as well as collaborate with the CAPA team anchor ensuring efficient handling and communication of CAPAs. You will work in close collaboration with the other QMs as well as International Study Managers (ISM), Clinical Quality Assurance (CQA) and CROs.
- Approximately 25 travel days per year should be expected
- We offer an interesting job in an ever more demanding area of the pharmaceutical industry.
- We invite you to be part of our Clinical Study Management department, where we share the common aspiration to become world-class in study execution.
- We are imaginative, passionate and responsible towards our deliveries, colleagues and society.
- We offer a positive and engaged working climate in a global environment.
The candidate is expected to possess the following qualifications:
- Relevant university degree in life science or similar education
- 6 - 8 years of documented experience working with international clinical studies
- Experience from authority inspections and audits by clinical QA
- In-depth understanding of the clinical trial processes, GCP and external regulations
- Profound insight into and interest in quality management
- Pro-active, responsible, an eye for quality and able to gain a helicopter view
- Thrives to work in a global environment
- A team player with strong communication skills, capable of interacting professionally with colleagues from different areas globally
- Fluent in written and spoken English
- Our company is a global pharmaceutical company specialized in psychiatric and neurological disorders.
- For more than 70 years, we have been at the forefront of research within neuroscience.
- Our key areas of focus are depression, schizophrenia, Parkinson's disease and Alzheimer's disease.
- An estimated 700 million people worldwide are living with psychiatric and neurological disorders and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences.
- Every day, we strive for improved treatment and a better life for people living with psychiatric and neurological disorders – we call this Progress in Mind.
- Our approximately 5,300 employees in 55 countries are engaged in the entire value chain throughout research, development, production, marketing and sales.
- Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries.