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.
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