Clinical Development Quality Lead
Vor 7 Tagen
Debiopharm, a pioneering biopharmaceutical company based in Switzerland, is seeking a highly skilled Clinical Development Quality Lead to join its dynamic team. As a key member of our Quality Management - R&D organization, you will play a crucial role in implementing our Quality Strategy and ensuring the success of our clinical trials.
About the RoleThe Clinical Development Quality Lead will be responsible for developing and implementing a risk-based compliance program to ensure the accuracy of documents and data, ultimately resulting in dossier acceptability by our out-licensing partners. This includes contributing to the selection and qualification of CROs, assessing their procedures, and guaranteeing compliance with regulatory requirements.
Key Responsibilities- Develop and implement a risk-based compliance program to ensure document and data accuracy.
- Contribute to the selection and qualification of CROs, assessing their procedures and ensuring compliance with regulatory requirements.
- Collaborate with the Clinical Trial Manager and other Functional Area Representatives to ensure proper DPI set-up and oversight of outsourced CRO activities.
- Provide compliance support and contribute to the oversight of quality events that may jeopardize the validity of clinical studies.
- Collaborate cross-functionally to develop and review critical clinical study documents to ensure cross-document consistency.
- Apply a risk-based approach to identify the need for and conduct co-auditing activities and quality visits with DPI and/or CRO representatives.
- Provide continuous compliance support by acting as an internal advisor on relevant procedures and regulations.
- Create Key Quality Indicators (KQIs) to identify areas for improvement based on risk-based compliance activities and audit observations.
- Lead or contribute to compound-specific Regulatory Authority Inspections and Due Diligence Activities.
- Build collaborative working relationships and ensure adequate communication within the compound-specific study team and cross-functional Quality peers.
- University Degree in Sciences or relevant academic background.
- 6-8 years' experience in the clinical setting of the pharmaceutical/biotech industry, including at least 3 years within Clinical Quality Management System & Compliance.
- Experience in managing and conducting GCP audits (CROs, TMF, Investigational Sites, and CSR).
- Excellent knowledge of GCP, current and strong working knowledge of GCP, CFR Title 21, and regulatory guidance's including ICH quality, clinical, multidisciplinary guidance documents, and 21 CFR Part 11 compliance.
- Strong experience in the mechanism of multiple QA vendor's oversight.
- Experience in setting and updating SOPs.
- Knowledge of computerized systems validation.
- Rigor, flexibility, adaptability, and organization.
- Pragmatism focused on efficiency and continuous improvement.
- Capacity to think strategically and to keep an overall view while bringing efficiency to daily detailed activities.
- Fluent in English, French an asset.
Debiopharm offers employees:
- An international, highly dynamic environment with a long-term vision.
- Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry.
- Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry.
- Participation in a company where innovation, people, and entrepreneurship are the fundamental keys to success.
- Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities.
-
Clinical Development Quality Lead
vor 3 Wochen
Lausanne, Waadt, Schweiz Aixial Group VollzeitClinical Development Quality LeadWe are seeking a highly skilled Clinical Development Quality Lead to join our team at Aixial Group, a leading CRO in Life Science.About Aixial GroupAixial Group is a CRO specialized in clinical research, providing technical support on clinical projects from phases I to IV and post-market.We operate in outsourcing, insourcing,...
-
Clinical Development Quality Lead
vor 1 Woche
Lausanne, Waadt, Schweiz Aixial Group VollzeitClinical Development Quality LeadWe are seeking a highly skilled Clinical Development Quality Lead to join our team at Aixial Group, a leading CRO in Life Science. As a Clinical Development Quality Lead, you will be responsible for ensuring the quality and integrity of our clinical projects from phases I to IV and post-market.Key Responsibilities:Develop and...
-
Clinical Development Quality Lead
vor 1 Monat
Lausanne, Waadt, Schweiz Debiopharm VollzeitJoin Debiopharm's Team as a Clinical Development Quality LeadDebiopharm, a leading biopharmaceutical company based in Switzerland, is seeking a highly skilled Clinical Development Quality Lead to join our team. As a key member of our Quality Management - R&D organization, you will play a crucial role in implementing our Quality Strategy and ensuring the...
-
Clinical Development Quality Lead
vor 1 Monat
Lausanne, Waadt, Schweiz Aixial Group VollzeitClinical Development Quality LeadWe are Aixial Group, a CRO specialized in Life Science, providing technical support on clinical projects from phases I to IV and post-market.Our team is developing activities in Switzerland, France, Belgium, Czech Republic, Denmark, UK, and more.We operate in outsourcing, insourcing, for pharmaceutical, cosmetic, medical...
-
Clinical Development Quality Lead
vor 3 Wochen
Lausanne, Waadt, Schweiz Debiopharm VollzeitJoin Debiopharm's Team as a Clinical Development Quality LeadDebiopharm, a leading biopharmaceutical company based in Switzerland, is seeking a highly skilled Clinical Development Quality Lead to join its team. As a key member of our Quality Management - R&D organization, you will play a crucial role in ensuring the quality and compliance of our clinical...
-
Clinical Development Quality Lead
vor 2 Wochen
Lausanne, Waadt, Schweiz Debiopharm VollzeitJoin Debiopharm's Team as a Clinical Development Quality LeadDebiopharm, a leading biopharmaceutical company based in Switzerland, is seeking a highly skilled Clinical Development Quality Lead to join our team. As a key member of our Quality Management - R&D organization, you will play a crucial role in ensuring the quality and compliance of our clinical...
-
Clinical Development Quality Lead
vor 2 Monaten
Lausanne, Waadt, Schweiz Aixial Group Vollzeit**Clinical Development Quality Lead Role**We are seeking a highly skilled Clinical Development Quality Lead to join our team at Aixial Group, a leading CRO in Life Sciences.About Aixial GroupAixial Group is a specialized CRO that provides technical support on clinical projects from phases I to IV and post-market. We work with laboratories to deliver...
-
Clinical Development Quality Lead
vor 2 Monaten
Lausanne, Waadt, Schweiz Debiopharm VollzeitAbout DebiopharmDebiopharm is a leading biopharmaceutical company dedicated to developing innovative therapies for oncology and infectious diseases. Our mission is to improve patient outcomes and quality of life through cutting-edge research and development.Job SummaryWe are seeking a highly skilled Clinical Development Quality Lead to join our team at...
-
Quality Assurance Specialist
vor 2 Monaten
Lausanne, Waadt, Schweiz Aixial Group Vollzeit**Clinical Development Quality Lead Role**We are seeking a highly skilled Clinical Development Quality Lead to join our team at Aixial Group, a leading CRO in the Life Science industry.About Aixial GroupAixial Group is a specialized CRO that provides technical support on clinical projects from phases I to IV and post-market. We work with laboratories to...
-
Global Clinical Trial Leader
vor 2 Monaten
Lausanne, Waadt, Schweiz Debiopharm VollzeitAbout DebiopharmDebiopharm is a privately-owned Swiss biopharmaceutical company dedicated to research in oncology and infectious diseases with the goal of improving patient outcomes and quality of life. Our company is committed to developing innovative therapies through our unique "development only" business model, acting as a bridge between disruptive...
-
Global Clinical Trial Leader
Vor 6 Tagen
Lausanne, Waadt, Schweiz Debiopharm VollzeitDebiopharm is a leading biopharmaceutical company dedicated to research in oncology and infectious diseases. We are committed to improving patient outcomes and quality of life through innovative therapies.About the RoleWe are seeking an experienced Global Clinical Trial Leader to join our team. As a key member of our clinical development team, you will be...
-
Global Clinical Trial Supply Manager
vor 2 Monaten
Lausanne, Waadt, Schweiz Debiopharm VollzeitAbout DebiopharmDebiopharm International SA is a privately-owned Swiss biopharmaceutical company dedicated to research and development in oncology and infectious diseases. Our mission is to improve patient outcomes and quality of life through innovative therapies.Job SummaryWe are seeking a highly skilled Global Clinical Trial Supply Manager to join our...
-
Global Clinical Trial Leader
vor 1 Monat
Lausanne, Waadt, Schweiz Debiopharm VollzeitGlobal Clinical Trial Leader - Oncology ResearchDebiopharm, a privately-owned Swiss biopharmaceutical company, is seeking a highly experienced Global Clinical Trial Leader to join our team. As a key member of our clinical development team, you will be responsible for leading global clinical trials in oncology from initiation to completion.Key...
-
Global Clinical Trial Manager
vor 4 Wochen
Lausanne, Waadt, Schweiz Debiopharm VollzeitGlobal Clinical Trial Leader Early PhaseDebiopharm, a privately-owned Swiss biopharmaceutical company, is seeking a highly experienced Global Clinical Trial Leader to join our team. As a key member of our clinical development team, you will be responsible for leading global clinical trials in oncology from initiation to completion.Key...
-
Global Clinical Trial Manager
Vor 3 Tagen
Lausanne, Waadt, Schweiz Debiopharm VollzeitAbout DebiopharmDebiopharm is a privately-owned Swiss biopharmaceutical company dedicated to research in oncology and infectious diseases to improve patient outcomes and quality of life. Our unique "development only" business model enables us to act as a bridge between disruptive discovery products and patient access in international markets.Role OverviewWe...
-
Global Clinical Supply Operations Manager
vor 3 Wochen
Lausanne, Waadt, Schweiz Debiopharm VollzeitDebiopharm is a Swiss biopharmaceutical organization committed to advancing research in oncology and infectious diseases to improve patient outcomes and enhance quality of life. Debiopharm International SA specializes in the development of innovative therapies through a distinctive 'development only' business model, connecting discovery products with patient...
-
Global Clinical Trial Supply Chain Manager
Vor 7 Tagen
Lausanne, Waadt, Schweiz Debiopharm VollzeitDebiopharm - A Leader in Oncology and Infectious DiseasesDebiopharm International SA is a privately-owned Swiss biopharmaceutical company dedicated to research in oncology and infectious diseases. Our mission is to develop innovative therapies that improve patient outcomes and quality of life.Job Title: Global Clinical Trial Supply ManagerWe are seeking a...
-
Global Clinical Trial Supply Chain Manager
vor 3 Wochen
Lausanne, Waadt, Schweiz Debiopharm VollzeitDebiopharm: A Leader in Oncology and Infectious DiseasesDebiopharm International SA is a privately-owned Swiss biopharmaceutical company dedicated to research in oncology and infectious diseases. Our mission is to develop innovative therapies that improve patient outcomes and quality of life.Job Title: Global Clinical Trial Supply ManagerWe are seeking a...
-
Global Clinical Trial Manager
vor 3 Wochen
Lausanne, Waadt, Schweiz Debiopharm VollzeitDebiopharm is a privately-owned Swiss biopharmaceutical firm dedicated to advancing research in oncology and infectious diseases to enhance patient outcomes and quality of life. Debiopharm International SA focuses on developing innovative therapies through our unique "development only" business model, bridging the gap between groundbreaking discovery...
-
Global Clinical Trial Supply Manager
vor 1 Monat
Lausanne, Waadt, Schweiz Debiopharm VollzeitGlobal Clinical Trial Supply ManagerDebiopharm, a privately-owned Swiss biopharmaceutical company, is seeking a highly skilled Global Clinical Trial Supply Manager to join our Pharmaceutical Development organization based at our Headquarters in Lausanne.This is an exciting opportunity to work on a diverse array of molecules, including small and large...