Lead Pharmacovigilance Quality Assurance Specialist
1 month ago
Company Overview
">Ascendis Pharma A/S, a U.S. publicly held biopharmaceutical company founded in Copenhagen, Denmark in 2007, is committed to addressing unmet medical needs.
">The company's mission is to develop new and potentially best-in-class therapies using their innovative platform technology.
">Headquartered in Copenhagen, Denmark, Ascendis Pharma has offices in Heidelberg, Germany and California, US.
">Salary and Benefits
">We offer an attractive remuneration package, including a salary of approximately $145,000 per year, based on location and industry standards.
">In addition to the competitive salary, we provide short- and long-term incentives, pension, and health insurance.
">Job Description
">We are seeking a highly motivated Senior PV Quality Manager to join our GVP Quality team in Hellerup, DK.
">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.
">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.
">You will also maintain up-to-date knowledge of regulatory requirements and ensure implementation of these in internal corporate procedures.
">Main Areas of Responsibility:
">- ">
- 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)">
Required Skills and Qualifications:
">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.
">As a GVP auditor, you must have experience in quality systems, compliance monitoring, and the development and maintenance of SOPs and training programs.
">Prior experience with auditing of computerized systems within the GVP regulated areas and medical device experience would be an advantage.
">Fluency in English, both written and spoken, is required.
">Benefits:
">This role offers a unique opportunity to work in a dynamic environment with a strong pipeline of products and a growing team.
">You will be part of a well-functioning group where you play an important role with your personality and competences.
">As a person, you are a highly motivated individual who enjoys being challenged and working in a collaborative environment.
">You value inter-departmental team relationships due to your excellent interpersonal, communication, analytical, and organizational skills.
">Travel Requirements:
">Due to significant international development and commercialization, you can expect around 30 travelling days per year.
-
Patient Handling Quality Assurance Specialist
2 months ago
Gentofte, Gentofte Kommune, Denmark Unique Human Capital AS Full timeJob Description:This role offers a unique opportunity to make a positive impact on patient care and support. As Patient Handling Quality Assurance Specialist, you will be responsible for ensuring the highest quality standards in patient handling equipment and services.About Us:We are a global leader in the development of innovative assistive devices and...
-
Senior GCP Quality Assurance Specialist
1 month ago
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeAbout the Role:We are seeking a highly skilled Senior GCP Quality Assurance Specialist to join our growing team at Ascendis Pharma A/S. This is an exciting opportunity to work in a dynamic and international environment with a short line of command.Job Description:The Senior GCP Quality Assurance Specialist will be responsible for ensuring compliance with...
-
Senior Quality Assurance Specialist
1 week ago
Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled Senior Quality Assurance Specialist to join our Finished Products Manufacturing (FPM) QA team at Novo Nordisk A/S. The ideal candidate will have experience in GMP inspections, quality processes, and stakeholder management.Key ResponsibilitiesPlan, conduct, and follow up on GMP inspections in collaboration with...
-
Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk A/S. This is an exciting opportunity to work in a fast-paced environment and contribute to ensuring high-quality products that transform lives.
-
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeAbout the RoleWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Ascendis Pharma A/S in Copenhagen, Denmark. This is an exciting opportunity to be part of a dynamic biopharmaceutical company that is transforming the lives of patients.The ideal candidate will have a strong background in Quality Assurance with experience in...
-
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeAbout the RoleWe are seeking an experienced Senior Quality Assurance Lead to join our Clinical Development team at Ascendis Pharma A/S.As a key member of our quality assurance team, you will be responsible for ensuring compliance with global regulations and maintaining high-quality standards in clinical development operations.This role is based in Hellerup,...
-
Gentofte, Gentofte Kommune, Denmark Unique Human Capital AS Full timeAre you passionate about ensuring the highest quality standards in patient handling? We are seeking a highly skilled Quality Assurance Specialist to join our team at Unique Human Capital A/S and drive excellence in quality management.
-
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeAt Ascendis Pharma A/S, we're driven by our passion for transforming patients' lives through innovative therapies. Our cutting-edge TransCon technology has enabled us to establish a fully integrated biopharmaceutical enterprise with a strong presence in Denmark, Germany, and the United States.We're currently seeking a skilled Development Quality Assurance...
-
Senior Pharmacovigilance and Compliance Manager
2 months ago
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeAbout the RoleWe are seeking a highly skilled Senior Pharmacovigilance and Compliance Manager to join our growing team at Ascendis Pharma A/S. As a key member of our Pharmacovigilance and Compliance Department, you will play a crucial role in ensuring the day-to-day operations of the QPPV Office, supporting the QPPV and deputy QPPV in maintaining our global...
-
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team in Copenhagen, Denmark. As a key member of our Development QA - Chemistry team, you will be responsible for ensuring the quality oversight of outsourced development activities at Contract Laboratories and Manufacturing Organizations.Job DescriptionResponsible for...
-
Senior GCP Quality Assurance Specialist
1 week ago
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeJob Description:In this exciting role at Ascendis Pharma, you will be part of the growing GCP Quality team, responsible for ensuring compliance and quality in clinical development and development operations. Your expertise will drive the implementation of effective processes, training, and standards to maintain an up-to-date knowledge of external...
-
Pharmacovigilance Compliance Manager
3 weeks ago
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeWe are seeking a skilled Pharmacovigilance Compliance Manager to join our team at Ascendis Pharma A/S, a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States.As a key member of our team, you will play a crucial role in ensuring the day-to-day operations of the QPPV Office, maintaining Ascendis Pharma's global PV...
-
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeAscendis Pharma A/S offers an exciting opportunity to join our GCP Quality team as a Senior Quality Assurance Manager. We are a leading biopharmaceutical company with locations in Denmark, Germany, and the United States.About UsWe apply our TransCon technology to build a fully integrated biopharmaceutical company focused on making a meaningful difference in...
-
Senior Patient Handling Quality Assurance Expert
4 weeks ago
Gentofte, Gentofte Kommune, Denmark Unique Human Capital AS Full timeAbout the RoleAs a Senior Patient Handling Quality Assurance Expert at Unique Human Capital A/S, you will be responsible for leading quality assurance activities within Patient Handling. This includes regulatory approvals, quality management system compliance, product quality, and process improvement.The ideal candidate will guide the organization in...
-
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeAbout UsAt Ascendis Pharma A/S, we are committed to making a meaningful difference in patients' lives through the development of innovative therapies. As a fast-growing biopharmaceutical company, we utilize our TransCon technology platform to address unmet medical needs.Job DescriptionWe are seeking a skilled and experienced QPPV Office Manager to join our...
-
Gentofte, Gentofte Kommune, Denmark Unique Human Capital AS Full timeAre you passionate about delivering exceptional quality and ensuring patient safety?In this role, you will be responsible for leading the quality assurance activities within the Patient Handling Division, including regulatory approvals, quality management system compliance, product quality, and process improvement.As a key member of our team, you will work...
-
Gentofte, Gentofte Kommune, Denmark Saxo Bank AS Full timeCopenhagen, DenmarkAbout the Role We are expanding our AML Quality Team at our headquarters in Copenhagen to elevate and monitor the AML quality of Saxo Bank. As a Senior Quality Assurance Analyst, you will be responsible for developing quality standards, conducting tests, identifying issues in our ONB and ODD processes, and reporting.This position involves...
-
Lead PV Quality Manager
3 weeks ago
Gentofte, Gentofte Kommune, Denmark Best Talent Full timeCompany OverviewAscendis Pharma A/S is a U.S. publicly held biopharmaceutical company founded in Copenhagen, Denmark in 2007. The company is committed to addressing unmet medical needs by applying its innovative platform technology to build a leading, fully integrated biopharma company.The company continues to expand into additional therapeutic areas to...
-
Quality Assurance Manager
2 months ago
Gentofte, Gentofte Kommune, Denmark Unique Human Capital AS Full timeDrive Quality ExcellenceAbout the Role: As a Quality Assurance Manager at Unique Human Capital A/S, you will play a vital role in ensuring the ongoing performance, safety, and compliance of our Patient Handling products. With direct report to the CEO of the Etac Patient Handling Division, you will work closely with the Etac Group Quality and Regulatory...
-
Environmental Safety and Quality Specialist
2 months ago
Gentofte, Gentofte Kommune, Denmark Ørsted Full timeCompany Overview\\Ørsted is a global leader in renewable energy, driving change towards a green energy future.\Salary\The estimated salary for this position is $80,000 - $120,000 per year, depending on location and experience.\Job Description\We are seeking an Environmental Safety and Quality Specialist to join our QHSE Assurance & Risk team. As a key...
