P2428 - CSV Senior Officer

Debiopharm is privately-owned Swiss biopharmaceutical company commitmented to research in oncology and infectious diseases in order 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, audit or other enquiries 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 system. 
• Coordinate Risk Analysis activities and document respective outcome, ensure mitigations are identified and managed
• Review, assess and approve 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
• Ensures 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)

• At least a bachelor’s in sciences or in IT with 5-6 years 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 inter-personal communication skills
• You are able to interact with technical experts and to advocate for Quality requirements are covered
• 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 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, we ensure offering to all our employees the same opportunities

The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.

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.

Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.