Associate Director, GCP and GVP Quality
Join the GCP and GVP Quality team in a leading and fast-growing biotech company.
Ascendis Pharma is currently expanding its GCP and GVP Quality with a quality and compliance position.
In GCP and GVP Quality you will together with a growing & dynamic quality team take part in the oversight of the compliance, quality, standards and training for Clinical Development and Development Operations areas, including the PV organization. You will maintain an up-to-date knowledge of external requirements and ensure implementation of these in internal corporate procedures. You will as quality assurance partner advise and support the Global Development and Development Operations to ensure compliance and continuous process optimization.
You will join a dedicated GCP and PV Compliance 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 (Hellerup).
Main areas of responsibility:
- As quality assurance partner collaborates with internal and external stakeholders to ensure appropriate GCP and GVP processes are implemented and maintained.
- Provides day-to-day expert quality & compliance advice on GCP and GVP processes to clinical teams.
- Leads subject matter experts in the maintenance of current SOPs and in the initiation and development of new procedures.
- Author and maintain SOPs owned by GCP and GVP Quality.
- Support Regulatory intelligence monitoring, assess impact and support implementation of new/updated GCP/GVP requirements on current practices and processes with relevant functions.
- Participates in the planning, conduct and follow-up on regulatory inspections.
- Collaborates with subject matter experts to formulate responses to audit/inspection findings relevant to GCP and GVP.
- Supports quality development activities within the Quality Management System.
- Perform expert consultation on complex aspects of GCP to projects teams and department.
- Perform the role of quality partner to assigned departments & project teams.
- Monitors Quality systems to proactively identify risk
Criteria of success in the role will be a proven ability to take responsibility and drive compliance initiatives to meet the ever growing and changing stringent global GCP & GVP 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 and/or GVP from clinical quality & compliance. You have extensive experience in quality systems, compliance monitoring, and the development and maintenance of SOPs and training programs. Depending on your knowledge base, the focus on either GCP or GVP may be adapted. Experience with computerized systems within GCP/GVP 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: 20-30 days per year.
Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbor, the canals, and the sea.
For more details about the job or the company, please contact: Helle Virenfeldt Sall, Director, GCP and GVP Quality on Mobile + 45 53770506 or firstname.lastname@example.org. All applications must be submitted in English and are treated confidentially.
Application will be evaluated when received, so please apply as soon as possible.
Something looks off?