Manager/Senior Manager, GCP Quality

Join theGCP Qualityteam in a leading and fast-growing biotech company.

Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States.

We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by our core values of patients, science, and passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Today, we have a growing pipeline of prodrug therapies in development, each designed to be a best-in-class therapy.

Ascendis Pharma is currently expanding its GCP and GVP Quality with a quality and compliance position.

In GCP 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. 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 team located in Hellerup, Denmark and Palo Alto, USA. This role is based in Hellerup, Denmark and reports directly to the Vice President, GCP and GVP Quality, based in Denmark (Hellerup).

Main areas of responsibility:

• Collaborate with internal and external stakeholders to ensure appropriate GCP processes are implemented and maintained.

• Provide day-to-day expert quality & compliance advice on GCP 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 Quality.
• Support Regulatory intelligence monitoring, assess impact and support implementation of new/updated GCP requirements on current practices and processes with relevant functions.
• Participate in the planning, conduct and follow-up on regulatory inspections.
• Collaborate with subject matter experts to formulate responses to audit/inspection findings relevant to GCP.
• 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.
• Monitor Quality systems to proactively identify risk.
• Support our Clinical trial supply team with IRT design and operation.

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 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 5 years of relevant experience in the pharmaceutical industry with significant experience in GCP from clinical quality & compliance. You have extensive experience in quality systems, compliance monitoring, and the development and maintenance of SOPs and training programs. Experience with computerized systems within GCP regulated areas and medical device experience would be an advantage.

You are proficient in English at a professional level, both written and spoken.

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. As Ascendis Pharma is an international biopharmaceutical company it is important that you are flexible to have overlap of work hours with our colleagues based in United States.

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: 20-30days per year.

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: Louise Moe Engström, VP, GCP and GVP Qualityon [email protected]. All applications must be submitted in English and are treated confidentially.

Application will be evaluated when received, so please apply as soon as possible.

Copenhagen