Senior PV Quality Manager
3 days ago
Company Overview
Ascendis Pharma A/S, a biopharmaceutical company founded in Copenhagen, Denmark in 2007, is dedicated to addressing unmet medical needs. The company utilizes its innovative platform technology to develop new and potentially best-in-class therapies, focusing on making a meaningful difference in patients' lives.
Headquartered in Copenhagen, Denmark, the company has offices in Heidelberg, Germany and California, US.
About the Role
We are seeking a Senior PV Quality Manager to join our growing team in Hellerup, DK. This exciting opportunity involves cross-functional collaborations and working with a well-functioning group where you will play an important role with your personality and competences.
Main Responsibilities
- Plan, perform, and report on GVP audits in collaboration with GVP colleagues internally and with stakeholders.
- 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).
Requirements
- You hold a master's degree in a scientific discipline.
- You have minimum 5-10 years of experience in the pharmaceutical industry with significant experience in GVP.
- You are a GVP auditor with experience in quality systems, compliance monitoring, and the development and maintenance of SOPs and training programs.
- You are proficient in English at a professional level, both written and spoken.
Talent Acquisition
This is a confidential recruitment process, and we will handle your application in a professional manner. Please forward your application marked "1885/Senior PV Quality Manager".
-
GVP Quality Lead
3 days ago
Gentofte, Gentofte Kommune, Denmark Best Talent Full timeJob DescriptionThe Senior PV Quality Manager will be responsible for ensuring the overall quality of Ascendis Pharma's PV activities. This includes performing GVP audits, reviewing and analyzing audit data, and providing expert compliance and regulatory advice.The ideal candidate will have a strong background in quality assurance, preferably in the...
-
Gentofte, Gentofte Kommune, Denmark Best Talent Full timeEstablished in Copenhagen, Denmark, Ascendis Pharma A/S is a U.S. publicly held biopharmaceutical company dedicated to addressing unmet medical needs. Guided by their core values of patients, science, and passion, the company leverages its innovative platform technology to develop new and potentially best-in-class therapies.With a strong focus on making a...
-
Pharmacovigilance Compliance Manager
3 days ago
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeAre you passionate about pharmacovigilance and compliance management?We are seeking a highly skilled Pharmacovigilance Compliance Manager to join our team at Ascendis Pharma. As a key member of the QPPV Office, you will play a crucial role in ensuring the day-to-day operations of the QPPV Office. You will support the QPPV and deputy QPPV in maintaining...
-
Senior GCP Quality Assurance Specialist
5 days ago
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeOverviewAscendis Pharma A/S is a fast-growing biopharmaceutical company with operations in Denmark, Germany, and the United States. We are dedicated to developing innovative therapies to address unmet medical needs.Job DescriptionAs a Senior GCP Quality Assurance Specialist, you will play a critical role in ensuring compliance with Good Clinical Practice...
-
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeAt Ascendis Pharma A/S, we are seeking a highly skilled Senior Quality Assurance Specialist to join our QA team in Copenhagen. This role will be responsible for driving the quality oversight of our development projects and collaborating with global teams to ensure the delivery of best-in-class products.About UsWe are a dynamic biopharmaceutical company...
-
Senior Business Insights Manager
9 hours ago
Gentofte, Gentofte Kommune, Denmark Ascendis Pharma AS Full timeAbout the Role:Ascendis Pharma A/S is seeking a highly skilled Senior Manager Competitive Intelligence to join our team. This is an exciting opportunity for a seasoned professional with a passion for competitive intelligence to drive business growth through data-driven insights.The Senior Competitive Intelligence Manager will play a critical role in...
-
Senior Management Coordinator
9 hours ago
Gentofte, Gentofte Kommune, Denmark Orsted Asia Pacific Full timeOrsted Asia Pacific seeks a highly organised and detail-oriented Senior Management Coordinator to support the Head of Offshore Wind Category Strategy and the wider leadership team.Company OverviewOur company develops, constructs, and operates offshore wind farms, striving to create a sustainable future.Job SummaryThis role involves providing administrative...
-
Senior Medical Contract Specialist
2 days ago
Gentofte, Gentofte Kommune, Denmark Job - Link ApS Full timeSenior Medical Contract SpecialistWe are seeking an experienced Senior Medical Contract Specialist to contribute to the success of our clients in the medical sector. As a key member of our team, you will be responsible for managing and negotiating contracts, ensuring compliance, and providing day-to-day leadership for projects varying from small-scale...
-
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeEstablished in Denmark, Germany, and the United States, Ascendis Pharma is a fast-growing biopharmaceutical company driven by its core values of patients, science, and passion. Our mission is to develop new and potentially best-in-class therapies to address unmet medical needs.We utilize our TransCon technology to build a leading, fully integrated...
-
Advanced Quality Assurance Specialist
20 hours ago
Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full timeJob OverviewWe are seeking a highly skilled Advanced Quality Assurance Specialist to join our QA API department in Copenhagen.This role is critical in ensuring the highest standards of quality and compliance within our organization. As an Advanced Quality Assurance Specialist, you will be responsible for establishing and maintaining quality standards in line...
-
Product Lifecycle Management Expert
5 days ago
Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full timeJob OverviewNovo Nordisk A/S is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases.We are seeking a highly skilled Senior Drug Product Manager to join our dynamic team. The successful candidate will be responsible for ensuring the smooth operation of marketed products while bringing new treatments...
-
GMP Quality Assurance Professional
2 days ago
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeWe are looking for a talented GMP Quality Assurance Professional to join our Development QA - Chemistry team at Ascendis Pharma A/S. In this role, you will play a pivotal part in ensuring the quality oversight of our outsourced development activities carried out at Contract Laboratories and Manufacturing Organizations.About Our CompanyAs a leading...
-
Gentofte, Gentofte Kommune, Denmark Evolve Full timeVi søger en erfaren og højt motiveret GRC Manager/Senior Manager/Director til at være en del af vores fremadskuende team.Ansvarsområder:Leve vor mission om at hjælpe virksomheder med at styrke deres governance og risikostyringsrammer gennem innovative løsningerLede projekter og koordinere tværfaglige teams for at sikre leverancer af høj...
-
Senior Mechanical Project Manager
5 days ago
Gentofte, Gentofte Kommune, Denmark Job - Link ApS Full timeJob OverviewAt Job-Link, we are actively seeking a Senior Mechanical Engineer with strong project management skills to lead medium to high complexity projects across diverse industries.Key ResponsibilitiesDevelop and implement mechanical engineering designs for components, systems, and plants.Prepare technical specifications and other project-related...
-
Gentofte, Gentofte Kommune, Denmark Saxo Bank AS Full timeCompany Overview:Copenhagen, Denmark - based Saxo Bank A/S is expanding its AML Quality Team at the headquarters in Copenhagen. The team is undergoing a transformation, focusing on quality assurance of Nordic and institutional clients to elevate and monitor the AML quality.About the Job:The successful candidate will be part of a pioneer group building the...
-
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeAscendis Pharma A/S invites highly skilled professionals to contribute to the quality oversight of outsourced development activities in a dynamic environment.The company, powered by innovative TransCon technology, creates fully integrated biopharmaceutical enterprises dedicated to transforming patient lives. Guided by core principles of patients, science,...
-
Quality Assurance Lead
5 days ago
Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full timeAbout the Role">We are seeking a Quality Assurance Lead to join our Finished Products Manufacturing (FPM) team at Novo Nordisk A/S. This is an exciting opportunity for a seasoned professional with a strong background in quality assurance and leadership. ">Job Description">The successful candidate will be responsible for leading the FPM QA support team,...
-
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeEmbark on an exciting career opportunity with Ascendis Pharma A/S, a fast-growing dynamic biopharmaceutical company. As our new Senior Regulatory Affairs Director for Global Strategy, you will play a pivotal role in driving the company's global strategy forward.Job Description:As a member of our Regulatory Affairs team, you will be responsible for developing...
-
Senior Data Analytics Developer
3 days ago
Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timeWe are seeking a highly motivated Senior/Principal Statistical Programmer to play a key role in developing drugs for unmet medical needs.Job OverviewAs a Senior/Principal Statistical Programmer at Ascendis Pharma A/S, you will be responsible for planning, managing, and executing programming projects to support clinical studies.Key ResponsibilitiesDevelop and...
-
Cost Engineer Lead
3 days ago
Gentofte, Gentofte Kommune, Denmark Orsted Asia Pacific Full timeJob Description: Senior Cost EstimatorWelcome to Orsted Asia Pacific, where you'll be working with a global team to bridge the cost engineering discipline with regional projects through development and maturation.Your Key Responsibilities:As a specialist in CAPEX cost estimation, you will work with scenarios, uncertainties, risks, and opportunities to...