Clinical Development Quality Lead

vor 2 Monaten

Lausanne, Waadt, Schweiz Debiopharm Vollzeit
About Debiopharm

Debiopharm 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 Summary

We are seeking a highly skilled Clinical Development Quality Lead to join our team at Debiopharm. As a key member of our Quality Management - R&D organization, you will be responsible for implementing our Quality Strategy and ensuring the compliance of our clinical trial activities.

Key Responsibilities
  • Develop and implement a risk-based compliance program to ensure document and data accuracy, resulting in dossier acceptability by out-licensing partners.
  • Contribute to the selection and qualification of CROs and vendors, ensuring compliance with regulatory requirements.
  • Collaborate with the Clinical Trial Manager and other functional area representatives to ensure proper setup 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, ensuring 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 to identify areas for improvement based on risk-based compliance activities and audit observations.
  • Lead/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.
  • Provide audit/CAPA support to the execution of the master audit plan and assist DPI business stakeholders in ensuring proper CAPA formulation and follow-up.
  • Support the development and 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 and 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 documents.
  • Strong experience in the mechanism of multiple QA vendor 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.
Benefits

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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