Assistant & Project Coordinator

Vor 6 Tagen

Lausanne, Schweiz Incyte Vollzeit

Debiopharm is a privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique “development only” business model, acting as a bridge between disruptive discovery products and patient access in international markets. At Debiopharm, you will be at the forefront of the fight against cancer and infectious diseases through working on innovative medicines for patients. Join our team at Debiopharm where together, we innovate, we impact, and we grow.

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

You contribute to the development of innovative treatments in Oncology & Anti-infectives by supporting the Computerized Systems Validation (CSV) Lead in endorsing, maintaining, and facilitating the appropriate compliance level for CSV activities. You assist with the implementation and writing of the required documentation. You apply the GAMP5 principles and other relevant standards applicable in an R&D driven organization with GxP and 21 CFR part 11 focus. You closely collaborate with the CSV Lead, Business Process Owner, and System Owner to create the synergy between business, Quality, and IT.

Your responsibilities will be but not limited to:

  • Drive the compliance excellence with GxP standards and internal quality guidelines.
  • Lead inspection readiness efforts alongside the validation team to ensure we’re always audit-ready.
  • Represent Quality during inspections, audits, or other inquiries on CSV matters (e.g., due diligence).
  • Oversee and evaluate CSV-related vendor documentation, ensuring vendor compliance.
  • Create/approve CSV deliverables and/or assist business units in writing CSV documentation (e.g., Validation Plan, Functional Requirements Specification, Test Scripts, Validation Report), and ensure proper filing in respective document management systems.
  • Coordinate Risk Analysis activities and document respective outcomes, ensuring mitigations are identified and managed.
  • Review, assess, and approve the implementation of changes in the area of responsibility (process, validation templates…).
  • Adopt a pragmatic, risk-based approach to balance quality with resources effectively.
  • Integrate CSV tasks into project planning, ensuring smooth project execution.
  • Ensure awareness of users on CSV and data integrity (authoring training documents and providing training).
  • Escalate serious risks and issues to Quality Management and other functions if applicable (e.g., IT, Business).

Requirements:

  • At least a bachelor’s in sciences or in IT with 5-6 years of working experience as CSV in the pharmaceutical industry, including at least 2 recent years in a clinical environment (GCP).
  • Extensive experience in a GCP environment; additional knowledge in GLP, GMP, and pharmacovigilance is a plus. Auditing experience in the pharmaceutical industry.
  • Interacting with regulatory authorities is a plus.
  • Proven Data Integrity experience.
  • Excellent writing skills for scientifically sound technical documents, instructions, validation protocols, and reports in English; French is an asset.
  • Working knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11, ...).
  • Strong analytical thinking and problem-solving ability.
  • You are a strong team player, with excellent interpersonal communication skills.
  • You are able to interact with technical experts and advocate for Quality requirements.
  • Strong multitasking and prioritization skills to support multiple projects and tasks effectively.
  • Proactive, self-motivated approach to managing assignments, ensuring timely completion.
  • Open to innovation and adaptable to change.
  • International, highly dynamic environment with a long-term vision.
  • Cross-functional collaboration at the forefront of the most advanced scientific developments in the 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.
  • Proud to be an Equal-Pay certified, ensuring equal opportunities for all employees.
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