Clinical Development Quality Lead

vor 2 Monaten

Lausanne, Waadt, Schweiz Debiopharm Vollzeit
Join Debiopharm's Team as a Clinical Development Quality Lead

Debiopharm, 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 success of our clinical trials.

About the Role

The Clinical Development Quality Lead will contribute to the development and implementation of quality strategies, policies, and procedures to ensure compliance with regulatory requirements and industry standards. You will work closely with cross-functional teams to identify and mitigate risks, ensure data accuracy, and maintain high-quality clinical trial documentation.

Responsibilities
  • Develop and implement risk-based compliance programs to ensure document and data accuracy.
  • 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 study setup and oversight of outsourced CRO activities.
  • Provide compliance support and contribute to the oversight of quality events that may impact the validity of clinical studies.
  • Collaborate cross-functionally to develop and review critical clinical study documents, ensuring consistency and accuracy.
  • Apply a risk-based approach to identify areas for improvement and conduct co-auditing activities with DPI and/or CRO representatives.
  • Provide continuous compliance support and act 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 study team and cross-functional quality peers.
Requirements
  • University degree in sciences or relevant academic background.
  • 6-8 years of experience in the clinical setting of the pharmaceutical/biotech industry, including at least 3 years in clinical quality management and compliance.
  • Experience in managing and conducting GCP audits (CROs, TMF, Investigational Sites, and CSR).
  • Excellent knowledge of GCP, CFR Title 21, and regulatory guidance documents, including ICH quality, clinical, and multidisciplinary guidance documents.
  • Strong 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 maintain an overall view while bringing efficiency to daily detailed activities.
  • Fluent in English, French an asset.
Benefits

Debiopharm offers employees a dynamic and international environment with a long-term vision. You will have the opportunity to work at the forefront of the most advanced scientific developments in oncology and anti-bacterial industries, collaborating with cross-functional teams and contributing to the development of innovative therapies. We are proud to be an Equal-Pay certified company, ensuring equal opportunities for all employees.

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