P2231 - Translational Medicine G(C)lp Quality Lead

vor 14 Stunden

Lausanne, Schweiz Debiopharm Vollzeit

**_Debiopharm_**_ is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally._
- At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target._

For our Quality Management organization based at our Headquarters in Lausanne, we are looking for a

**Translational Medicine G(c)LP Quality Lead**

In this newly created position, you will advocate the quality culture and mindset throughout Debiopharm Translational Medicine (TM) Organization, from TM Pre-clinical to TM Clinical departments.

**Your responsibilities will be but not limited to**:

- Contribute to Vendor selection and qualification process, assess Vendor’s procedures during selection process, guaranteeing compliance with regulatory requirements & verify G(c)LP certification, for TM vendors contributing to numerous PK & biomarkers assessments in DPI’s pre-clinical and clinical programs
- Collaborate with the TM Subject Matter Experts to ensure proper DPI set-up & oversight of outsourced activities
- Support “risk / impact assessments” related to TM activities & respective vendors contributing to DPI pre-clinical and clinical programs
- Provide continuous compliance support by acting as an internal advisor on relevant procedures and regulations to ensure correct interpretation and proper implementation
- 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 / Due Diligence Activities
- Build collaborative working relationships and ensure adequate communication within the TM organization and cross-functional Quality peers
- Work with the TM business stakeholders to ensure proper CAPA development and follow-up
- Contribute to the development / maintenance of Quality and Translational Medicine related Procedural Documents
- Ensure training on proper knowledge and understanding on latest G(c)LP guidelines, DPIs Procedural Documents and regulations of identified stakeholders

**Requirements**:

- Master’s degree in a scientific discipline or equivalent combination of education and experience
- 7 - 10 years’ experience in the Pharmaceutical of Biotechnology industry with a minimum of 5 years in Quality Management or Regulatory Compliance Role
- Current and strong working knowledge in GLP, GcLP and regulatory guidances including, ICH, quality, non-clinical, clinical, multidisciplinary guidance documents and 21 CFR Part 11 compliance
- Ability to present complex issues in a way that is understandable cross-functionally and at all levels of the organization
- Strong problem solving and analytical skills
- Knowledge of root cause analysis tools / methodologies
- Strong team player, with excellent interpersonal communication skills
- Used to simultaneously support multiple projects, duties and assignments and prioritize accordingly
- Self-dependent way of working; taking ownership of assigned tasks; plan and deliver according to agreed timelines
- Excellent communication skill in English (both oral & written) ; French is an asset

**Benefits**
- 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.
- Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm._

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