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Associate Director, GCP and PV Regulatory Compliance Job in Denmark
Ascendis Pharma , Denmark

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1 Year
0 - 0
Job Type
Job Shift
Job Category
Requires Traveling
Career Level
As mentioned in job details
Total Vacancies
1 Job
Posted on
Apr 13, 2021
Last Date
Jul 13, 2021

Job Description

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:

  • Collaborates with internal and external stakeholders to ensure appropriate GCP and PV systems are implemented and maintained.
  • Reviews and analyzes audit, inspection and CAPA data to identify compliance trends and areas of exposure related to pharmacovigilance.
  • Plans, performs, and reports on GCP and PV quality audits.
  • Provides expert compliance advice on GCP and PV strategies, programs, processes, initiatives, and activities to help manage and mitigate risk.
  • Collaborates, liaises, and supports all Ascendis functional groups contributing to the PSMF to ensure they provide the required information on time for the PSMF update.
  • Periodically reviews existing Standard Operating Procedures (SOPs) relative to Development Operations and the PV function within Ascendis to determine the need for changes and updates of existing documents and the initiation of new procedural documents.
  • Leads subject matter experts in the modification of current SOPs and in the initiation and development of new procedures.
  • Provides inspection readiness activities including but not limited to monitoring for non-compliance and ensuring responsible functions mitigate risks.
  • Collaborates with QA Training to conduct inspection readiness training, one-one practice sessions and mock audits as needed.
  • Assesses impact of changes in new GCP and PV regulations and guidance on current practices and processes and coordinate with other functions for updates as needed.
  • Oversees Development Operations, Clinical Development, PV, and Commercial Operations initiatives and adherence to regulatory requirements.
  • Prepares periodic metric reports depicting non-compliance with internal procedures; and the review, monitoring and trending root cause analyses for non-compliance metrics.
  • Collaborates with subject matter experts and senior management to formulate responses to audit/inspection findings relevant to GCP and PV issues.
  • Reviews records of internal and external audit deficiencies to identify gaps, conduct non-compliance investigations and communicate with functional heads in preparing, prioritizing, and monitoring the mitigation schedule.

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 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 Annette Derouin, Director, GCP and Pharmacovigilance Regulatory Complianceon M + 45 30 80 58 52 or . All applications must be submitted in English and are treated confidentially.

Job Specification

Ascendis Pharma

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