Lead Pharmacovigilance Quality Assurance Specialist

5 days ago

Gentofte, Gentofte Kommune, Denmark Best Talent Full time

Company Overview

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Ascendis Pharma A/S, a U.S. publicly held biopharmaceutical company founded in Copenhagen, Denmark in 2007, is committed to addressing unmet medical needs.

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The company's mission is to develop new and potentially best-in-class therapies using their innovative platform technology.

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Headquartered in Copenhagen, Denmark, Ascendis Pharma has offices in Heidelberg, Germany and California, US.

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Salary and Benefits

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We offer an attractive remuneration package, including a salary of approximately $145,000 per year, based on location and industry standards.

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In addition to the competitive salary, we provide short- and long-term incentives, pension, and health insurance.

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Job Description

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We are seeking a highly motivated Senior PV Quality Manager to join our GVP Quality team in Hellerup, DK.

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As a key member of our quality assurance team, you will be responsible for ensuring compliance with regulatory requirements and developing processes to support the growing demand for high-quality pharmacovigilance services.

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Your primary areas of responsibility will include planning, performing, and reporting on GVP audits, reviewing and analyzing audit, inspection, deviation, and CAPA data, and providing expert compliance and regulatory advice on GVP.

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You will also maintain up-to-date knowledge of regulatory requirements and ensure implementation of these in internal corporate procedures.

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Main Areas of Responsibility:

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  • Plan, perform and report on GVP audits in collaboration with GVP colleagues internally and with stakeholders e.g. related to vendor audits">
  • Review and analyze audit, inspection, deviation, and CAPA data to identify root cause, compliance trends and areas of exposure related to GVP">
  • Prepare periodic compliance metric reports and conduct non-compliance investigations">
  • Provide expert compliance and regulatory advice on GVP">
  • Author and maintain procedures owned by GVP Quality">
  • Support Regulatory Intelligence monitoring and assess impact and support implementation of new/updated GVP requirements on current practices and processes">
  • Support the planning, conduct and follow-up on regulatory inspections">
  • Collaborate with subject matter experts to formulate responses to inspection findings relevant to GVP">
  • Support quality development initiatives within the GVP area">
  • Perform consultation on complex aspects of GVP">
  • Perform the role of Quality Partner to PV Operation (US/DK) and the EU QPPV">
  • Support the monitoring of PV Quality systems to proactively identify risks">
  • Support PV vendor oversight and qualification (e.g. quality agreements and other contracts)">
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Required Skills and Qualifications:

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To be successful in this role, you will need to have a master's degree in a scientific discipline and at least 5-10 years of experience in the pharmaceutical industry with significant experience in GVP.

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As a GVP auditor, you must have experience in quality systems, compliance monitoring, and the development and maintenance of SOPs and training programs.

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Prior experience with auditing of computerized systems within the GVP regulated areas and medical device experience would be an advantage.

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Fluency in English, both written and spoken, is required.

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Benefits:

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This role offers a unique opportunity to work in a dynamic environment with a strong pipeline of products and a growing team.

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You will be part of a well-functioning group where you play an important role with your personality and competences.

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As a person, you are a highly motivated individual who enjoys being challenged and working in a collaborative environment.

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You value inter-departmental team relationships due to your excellent interpersonal, communication, analytical, and organizational skills.

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Travel Requirements:

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Due to significant international development and commercialization, you can expect around 30 travelling days per year.

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