P2336 - Clinical Development Quality Lead
vor 2 Wochen
Social network you want to login/join with:
P2336 - Clinical Development Quality Lead, LausanneClient: Debiopharm
Location: Lausanne
Job Category: Other
Job Reference: 62d34ec9bb35
Job Views: 8
Posted: 21.01.2025
Expiry Date: 07.03.2025
Job Description:Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.
At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.
For our Quality Management – R&D organization based at our Headquarters in Lausanne, we are looking for a
Clinical Development Quality Lead
Mission:
The Clinical Development Quality Lead contributes to the implementation of the Quality Strategy in order to support Debiopharm International’s day-to-day clinical trial activities from a cross-functional end-to-end perspective by applying the “pro-active quality principles” and providing continuous support and input during the Clinical Development Activities.
Your responsibilities will be but not limited to:
- Develop a “risk-based” compound-specific compliance program contributing to document/data accuracy, ultimately resulting in “dossier acceptability” by respective out-licensing partners (emphasis on eCTD Module 5).
- Contribute to CRO/Vendor selection and qualification process, assess relevant CROs procedures during selection process to establish a pro-active quality approach, guaranteeing compliance with regulatory requirements.
- Collaborate with the Clinical Trial Manager and other Functional Area Representatives in the Study Team to ensure proper DPI set-up & oversight of outsourced CRO activities, with primary focus on critical data points (primary endpoints) and critical processes.
- Provide compliance support and contribute to “in process / ongoing” oversight through evaluation & follow-up on reported quality events potentially jeopardizing the validity of the clinical study.
- Collaborate cross-functionally to the development and review of critical clinical study documents to ensure cross-document consistency IB versus Clinical Trial Protocol versus Master Informed Consent Form.
- Applying the risk-based approach, identify the need to & conduct co-auditing activities / quality visits with DPI and/or CRO representatives.
- Provide continuous compliance support by acting as an internal advisor on relevant procedures and regulations to ensure correct interpretation and proper implementation.
- Create KQI to identify areas for improvement based on risk-based compliance activities and audit observations.
- Lead/contribute to compound-specific Regulatory Authority Inspections/Due Diligence Activities.
- Build collaborative working relationships and ensure adequate communication within the compound-specific study team and cross-functional Quality peers, assist in driving change to build a culture of compliance throughout the Clinical Development organization.
- Provide Audit/CAPA support to the execution of Master Audit Plan executed, assist the DPI business stakeholders to ensure proper CAPA formulation and follow-up.
- Provide support to the development/maintenance of QM and ClinDev related Procedural Documents.
Requirements:
- 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).
- Excellence 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:
- 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.
-
P2336 - Clinical Development Quality Lead
vor 2 Stunden
Lausanne, Waadt, Schweiz Debiopharm VollzeitDebiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative...
-
Clinical Development Quality Team Lead
vor 20 Stunden
Lausanne, Schweiz Debiopharm VollzeitDescription Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to...
-
Clinical Development Quality Lead
vor 1 Tag
Lausanne, Waadt, Schweiz Aixial Group VollzeitClinical Development Quality Lead (M/F) Location : Lausanne, Switzerland Who is Aixial Group ? Aixial Group, we are a CRO (Clinical Research Organization), specialized in Life Science. We work with laboratories to provide technical support on clinical projects from phases I to IV and post market. Since 2014, we have been part of the Alten...
-
Clinical Development Quality Lead
Vor 6 Tagen
Lausanne, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Clinical Development Quality Lead (M/F), Lausanne DistrictClient:Aixial GroupLocation:Lausanne DistrictJob Category:OtherJob Reference:82e2055b394dJob Views:15Posted:06.03.2025Expiry Date:20.04.2025Job Description:Who is Aixial Group?Aixial Group is a CRO (Clinical Research Organization) specialized in Life Science....
-
Clinical Development Quality Lead
vor 2 Wochen
Lausanne, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Clinical Development Quality Lead (M/F), LausanneClient: Aixial GroupLocation: LausanneJob Category: OtherJob Reference: 82e2055b394dJob Views: 9Posted: 21.01.2025Expiry Date: 07.03.2025Job Description:Who is Aixial Group?Aixial Group is a CRO (Clinical Research Organization) specialized in Life Science. We work...
-
Global Clinical Development Lead
vor 2 Wochen
Lausanne, Schweiz Nestle Operational Services Worldwide SA Vollzeit**Position Snapshot** Location: Nestlé Health Science Lausanne, Switzerland Company: Nestlé Health Science Act. Rate: Full-Time Act. Rate 100% Type of contract: Permanent contract **What we offer at Nestlé** Flexible work policies in terms of core hours and working from home. Please talk to us during the recruitment process about what flexibility could...
-
Clinical Operations Quality Management
Vor 6 Tagen
Lausanne, Waadt, Schweiz TN Switzerland VollzeitDiscover Your Role in Clinical QualityAixial Group's Clinical Development Quality Leads work collaboratively with cross-functional teams to ensure compliance with regulatory requirements, industry standards, and internal policies.We foster a culture of continuous learning, encouraging our professionals to stay updated on the latest clinical research trends,...
-
Quality Assurance Specialist Clinical Trials
Vor 6 Tagen
Lausanne, Waadt, Schweiz TN Switzerland VollzeitExpertise in Clinical QualityClinical Development Quality Leads at Aixial Group possess extensive knowledge of clinical trials regulations, standards, and best practices. Our team ensures seamless project execution, adhering to strict quality criteria and timelines.We collaborate with laboratories to provide specialized support on complex clinical projects,...
-
Clinical Development Quality Lead Position
Vor 6 Tagen
Lausanne, Waadt, Schweiz TN Switzerland VollzeitAbout Aixial GroupAixial Group is a leading CRO specializing in Life Science, providing technical support for clinical projects from phases I to IV and post-market. As part of the Alten family since 2014, we have established a strong presence in Switzerland, France, Belgium, Czech Republic, Denmark, UK, US, and are continuously expanding our international...
-
Biotech Clinical Development Manager
Vor 6 Tagen
Lausanne, Waadt, Schweiz Antaes Consulting VollzeitAntaes Consulting is a pioneering biotech at the forefront of neurodegenerative disease research, developing next-generation therapies for Alzheimer's, Parkinson's, and related disorders.We're redefining how we approach precision medicine, biomarker innovation, and early-stage drug development using cutting-edge technologies.Our team is searching for a...
-
Neurology Clinical Lead Neuroimmunology
Vor 4 Tagen
Lausanne, Waadt, Schweiz TN Switzerland VollzeitCompany OverviewTN Switzerland is a pioneering biotech company at the forefront of neurodegenerative disease research. We develop next-generation therapies for Alzheimer's, Parkinson's, and related disorders using cutting-edge technologies. Our team is passionate about shaping the future of neurotherapeutics and redefining precision medicine, biomarker...
-
P2416 - Global Clinical Trial Leader
vor 3 Wochen
Lausanne, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:P2416 - Global Clinical Trial Leader, LausanneClient: DebiopharmLocation:Job Category: OtherJob Reference: cdec27b0db6fJob Views: 10Posted: 19.02.2025Expiry Date: 05.04.2025Job Description:Debiopharm is a privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases to...
-
P2416 - Global Clinical Trial Leader
vor 1 Woche
Lausanne, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:P2416 - Global Clinical Trial Leader, Lausanne DistrictClient: DebiopharmLocation: Lausanne DistrictJob Category: OtherJob Reference: cdec27b0db6fJob Views: 4Posted: 03.03.2025Expiry Date: 17.04.2025Job Description:Debiopharm is a privately-owned Swiss biopharmaceutical company committed to research in oncology and...
-
Clinical Development Manager Neurology
Vor 4 Tagen
Lausanne, Waadt, Schweiz headcount | recruitment driven by scientists Vollzeit**Neurodevelopment and Innovation**About the RoleWe are a science-driven biotech with an ambitious pipeline, and we are looking for a talented Director of Neurodevelopment and Innovation to lead our clinical development efforts in neuroimmunology.In this role, you will have the opportunity to work with a highly experienced team, develop cutting-edge...
-
Medical director clinical development neurology
vor 18 Stunden
Lausanne, Schweiz Headcount AG VollzeitJoin a pioneering biotech at the forefront of neurodegenerative disease research , developing next-generation therapies for Alzheimer’s, Parkinson’s, and related disorders. Using cutting-edge technologies, this company is redefining how we approach precision medicine, biomarker innovation, and early-stage drug development. Now, they’re searching for a...
-
Lausanne, Schweiz Debiopharm VollzeitDescription Debiopharm is dedicated to advancing patient care through innovative therapies in oncology and infectious diseases. As a privately-owned Swiss biopharmaceutical company, we employ a unique “development only” business model focused on developing high-impact therapies that can make a significant difference in patient lives. Join us at...
-
Lausanne, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:P2501 - Clinical Development Principal Biostatistician, Lausanne DistrictClient:DebiopharmLocation:Job Category:OtherJob Reference:b84f4c5f5a88Job Views:6Posted:03.03.2025Expiry Date:17.04.2025Job Description:Debiopharm is dedicated to advancing patient care through innovative therapies in oncology and infectious...
-
Group Leader Clinical Innovation Lab
vor 2 Wochen
Lausanne, Schweiz Nestlé SA VollzeitImportant Information: After submitting your application, you will be automatically invited to record a video introduction guided by specific questions. This video introduction should take no longer than 10 minutes. Once this step is completed, we would be pleased to consider your application and assess your profile accordingly. Kindly be informed that we...
-
Lausanne, Schweiz Debiopharm VollzeitDebiopharm is dedicated to advancing patient care through innovative therapies in oncology and infectious diseases. As a privately-owned Swiss biopharmaceutical company, we employ a unique "development only" business model focused on developing high-impact therapies that can make a significant difference in patient lives. Join us at Debiopharm to engage in...
-
Medical Director Clinical Development Neurology
Vor 4 Tagen
Lausanne, Schweiz headcount | recruitment driven by scientists VollzeitMedical Director Clinical Development Neurology (BH-2099-2)Location: Lausanne, SwitzerlandSector: PharmaceuticalsSalary: 180,000.00 CHF per annumJoin a pioneering biotech at the forefront of neurodegenerative disease research, developing next-generation therapies for Alzheimer’s, Parkinson’s, and related disorders. Using cutting-edge technologies, this...
