Join theGCP and GVP Quality team in a leading and fast-growing biotech company.
Ascendis Pharma is currently expanding its GCP and GVP Quality with a GCP auditor position.
In GCP and GVP Quality you will together with a growing amp; dynamic quality team take part in the oversight of the compliance, quality, standards and training for the Clinical Development and Development Operations areas, including Pharmacovigilance. You will maintain an up-to-date knowledge of regulatory requirements and ensure implementation of these in internal corporate procedures. Your primary area of responsibility will be the GCP area, including performance of GCP audits.
You will join a dedicated GCP and GVP Quality team of8 colleagues located in Hellerup, Denmark and Palo Alto, USA. This role is based in Hellerup, Denmark and reports directly to the Director, GCP and GVP Quality based in Denmark.
Main areas of responsibility:
Criteria of success in the role will be a proven ability to take and be responsible for decisions to meet the ever growing and changing stringent global GCP requirements. Furthermore, a strong quality mindset and attention to detail in establishing priorities, scheduling, and meeting deadlines.
You hold a master’s degree in a scientific discipline and have minimum 8-10 years of experience in the pharmaceutical industry with significant experience in GCP from clinical Quality. You have experience as a GCP auditor and extensive experience in quality systems, compliance monitoring, and the development and maintenance of SOPs and training programs. Experience with auditing of computerized systems within the GCP/PV regulated areas and medical device experience would be an advantage.
You are proficient in English at a professional level, both written and spoken, and you master MS Office.
You are a highly motivated individual who enjoys being challenged and working in collaborative environments. You value inter-departmental team relationships using your excellent interpersonal, communication, analytical, and organizational skills.
Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues to advance our exciting product pipeline.
Travelling: Approximately 30-40 days on a yearly basis.
Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbour, the canals, and the sea.
For more details about the job or the company, please contact Helle Virenfeldt Sall, Director, GCP and GVP Qualityon Mobile + 45 53770506 or . All applications must be submitted in English and are treated confidentially.
Applications will be evaluated when received, so please apply as soon as possible.