Audit & Capa Lead (P2307)

vor 5 Stunden

Lausanne, Schweiz Debiopharm Vollzeit

Description

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

Audit & CAPA Lead

**Your responsibilities will be but not limited to**:
Audit & CAPA process owner
On behalf of the Head of Quality, act as business owner for “Audit & CAPA System”: single point of contact to adequately support the Quality & Business representatives with regards to system related questions.
Ensure the risk-based audit strategy is properly applied, in close collaboration with the GxP Quality Leads and the Business Partners.
Create & maintain global GxP audit programs (in line with business priorities and timelines) materialized by means of a Master Audit Plan.
In line with the outsourced audit model, select qualified auditors to timely execute the agreed Master Audit Plan covering 3rd parties, systems, processes, studies, documents, etcto adequately assess compliance with DPI Procedural Documents and applicable regulations.
Manage all audit activities starting from audit planning, preparing, execution up to delivering final report.
Contribute to preparation and conduct activities of Regulatory Authority Inspections.
Work with GxP Quality Lead in view of adequate and timely CAPA development.
Oversee / Manage Quality Coordinator to populate the Audit / CAPA system as per Audit / CAPA process requirements.
Develop meaningful Audit / CAPA metrics allowing proper oversight / follow-up by business representatives (owners & department heads).
Generate Audit / CAPA metrics to indicate areas for improvement and to drive continuous improvement initiatives.
**Requirements**:
**University degree**: Pharmacist Diploma, PhD, master’s in science
5 to 8 years’ experience in managing quality assurance within the pharmaceutical industry and/or Biotech companies
Minimum 3 years’ experience with GxP Audits
Minimum 3 years ‘experience in managing tracking systems such as CAPAs database resulting from GxP audits (ex for GCP: CROs, TMF, Investigational Sites and CSR) as well as deviations, changes tracking systems
Solid knowledge of GxP
Good practical experience in using validated electronic quality systems tools (TrackWise, Veeva, Ennov, etc)
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

**Benefits**:
Debiopharm can offer you

Possibility to work from home with weekly visit in the office (Lausanne)
The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry
The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success
Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities

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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