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Clinical Quality Assurance Expert

vor 1 Woche

Lausanne, Waadt, Schweiz Debiopharm Vollzeit

Debiopharm is an independent biopharmaceutical company dedicated to improving patient outcomes and quality of life through innovative research in oncology and infectious diseases. Our unique approach combines drug development, manufacturing, and digital health investment to address high unmet medical needs.

We are seeking a Clinical Development Quality Lead to join our Quality Management team at our headquarters in Lausanne. This role will contribute to the implementation of our Quality Strategy, ensuring compliance with regulatory requirements and industry standards.

Clinical Development Quality Lead

Mission :

The Clinical Development Quality Lead plays a crucial role in supporting Debiopharm's clinical trial activities by applying proactive quality principles and providing continuous input and support throughout the clinical development process.

Your responsibilities will include :

  1. Developing a risk-based compliance program to ensure document and data accuracy, resulting in dossier acceptability by out-licensing partners.
  2. Contributing to CRO and vendor selection and qualification processes, assessing relevant procedures to establish a proactive quality approach and guaranteeing compliance with regulatory requirements.
  3. Collaborating with the Clinical Trial Manager and other Functional Area Representatives to ensure proper DPI setup and oversight of outsourced CRO activities, focusing on critical data points and processes.
  4. Providing compliance support and contributing to ongoing oversight through evaluation and follow-up on reported quality events that may jeopardize the validity of the clinical study.
  5. Cross-functionally collaborating to develop and review critical clinical study documents to ensure consistency across IB, Clinical Trial Protocol, and Master Informed Consent Form.
  6. Applying a risk-based approach to identify the need for and conduct co-auditing activities and quality visits with DPI and/or CRO representatives.
  7. Providing continuous compliance support by acting as an internal advisor on relevant procedures and regulations to ensure correct interpretation and proper implementation.
  8. Creating KQI to identify areas for improvement based on risk-based compliance activities and audit observations.
  9. Leading/contributing to compound-specific Regulatory Authority Inspections/Due Diligence Activities.
  10. Buiding collaborative working relationships and ensuring adequate communication within the compound-specific study team and cross-functional Quality peers, assisting in driving change to build a culture of compliance throughout the Clinical Development organization.
  11. Providing Audit/CAPA support to the execution of the Master Audit Plan, assisting DPI business stakeholders to ensure proper CAPA formulation and follow-up.
  12. Supporting the development/maintenance of QM and ClinDev-related Procedural Documents.

Requirements :

  1. University Degree in Sciences or relevant academic background.
  2. 6-8 years' experience in the clinical setting of the pharmaceutical/biotech industry, including at least 3 years within Clinical Quality Management System & Compliance.
  3. Experience in managing and conducting GCP audits (CROs, TMF, Investigational Sites, and CSR).
  4. Excellent knowledge of GCP, current and strong working knowledge of GCP, CFR Title 21, and regulatory guidelines, including ICH quality, clinical, multidisciplinary guidance documents, and 21 CFR Part 11 compliance.
  5. Strong experience in multiple QA vendor oversight.
  6. Experience in setting and updating SOPs.
  7. Knowledge of computerized systems validation.
  8. Rigor, flexibility, adaptability, and organization.
  9. Pragmatism focused on efficiency and continuous improvement.
  10. Capacity to think strategically and keep an overall view while bringing efficiency to daily detailed activities.
  11. Fluent in English, French an asset.

Debiopharm offers :

  1. An international, dynamic environment with a long-term vision.
  2. Cross-functional collaboration at the forefront of advanced scientific developments in oncology and anti-bacterial industries.
  3. Exposure to various areas and functions within clinical development and the pharmaceutical industry.
  4. Participation in a company where innovation, people, and entrepreneurship are key to success.
  5. Proud to be an Equal-Pay certified company, offering equal opportunities to all employees.