Join theGCP and Pharmacovigilance Regulatory Complianceteam in a leading and fast-growing biotech company.
Ascendis Pharma is currently expanding its GCP and PV Compliance area.
You will become responsible for the oversight of the compliance, quality, standards and training for Global Development and Development Operations, including the PV organization. You will establish and execute global GCP and PV processes, standards, and compliance monitoring systems. Additionally, you will be responsible for ensuring compliance with GCP and PV corporate policies and internal procedures, global regulations, and guidelines. You will ensure GCP and PV Inspection Readiness and continuous process improvement.
You will join a dedicated GCP and PV Compliance team of6 colleagues located in Hellerup, Denmark and Palo Alto, USA. This role is based in Hellerup, Denmark and reports directly to the Director, GCP and Pharmacovigilance Regulatory Compliance.
Main areas of responsibility:
Criteria of success in the role will be a proven ability to strategically make and be accountable for decisions to meet the ever growing and changing stringent global GCP requirements. Furthermore, strong 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 and/or PV. You have extensive experience in quality systems, establishing and tracking metrics, compliance monitoring, and the development and maintenance of SOPs and training programs. Understanding of large-scale electronic data storage and retrieval systems within the GCP/PV regulated areas is a plus.
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: 10-20 days per year.
Place of work: Ascendis Pharma