Quality Assurance Specialist

Vor 4 Tagen

Lausanne, Waadt, Schweiz Debiopharm Vollzeit

Our mission at Debiopharm is to improve patient outcomes and quality of life through innovative research in oncology and infectious diseases. As a Clinical Development Quality Lead, you will play a vital role in ensuring the quality and compliance of our clinical trials.

Clinical Development Quality Lead

Key Responsibilities :

The Clinical Development Quality Lead will be responsible for implementing our Quality Strategy, ensuring that our clinical trials meet the highest standards of quality and compliance. Key responsibilities will include :

  1. Developing and implementing a risk-based compliance program.
  2. Contributing to the selection and qualification of CROs and vendors.
  3. Collaborating with the Clinical Trial Manager and other Functional Area Representatives to ensure proper DPI setup and oversight of outsourced CRO activities.
  4. Providing compliance support and contributing to ongoing oversight through evaluation and follow-up on reported quality events.
  5. Cross-functionally collaborating to develop and review critical clinical study documents.
  6. Applying a risk-based approach to identify the need for and conduct co-auditing activities and quality visits.
  7. Providing continuous compliance support and guidance to the team.
  8. Creating Key Quality Indicators (KQI) to identify areas for improvement.
  9. Leading/contributing to Regulatory Authority Inspections/Due Diligence Activities.
  10. Buiding collaborative working relationships and ensuring adequate communication within the study team and cross-functional Quality peers.
  11. Providing Audit/CAPA support to the execution of the Master Audit Plan.
  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.

Join Our Team :

  1. 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.

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