Clinical Development Quality Lead (P2336)

Clinical Development Quality Lead (P2336)

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 – R&D organization based at our Headquarters in Lausanne, we are looking for a

Clinical Development Quality Lead

Mission:

The Clinical Development Quality Lead contributes to the implementation of the Quality Strategy in order to support Debiopharm International’s day-to-day clinical trial activities from a cross-functional end-to-end perspective by applying the “pro-active quality principles” and providing continuous support and input during the Clinical Development Activities.

Your responsibilities will be but not limited to:

• Develop a “risk-based” compound-specific compliance program contributing to document / data accuracy, ultimately resulting in “dossier acceptability” by respective out-licensing partners (emphasis on eCTD Module 5)


• Contribute to CRO/Vendor selection and qualification process, assess relevant CROs procedures during selection process to establish a pro-active quality approach, guaranteeing compliance with regulatory requirements


• Collaborate with the Clinical Trial Manager and other Functional Area Representatives in the Study Team to ensure proper DPI set-up & oversight of outsourced CRO activities, with primary focus on critical data points (primary endpoints) and critical processes


• Provide compliance support and contribute to “in process / ongoing” oversight through evaluation & follow-up on reported quality events potentially jeopardizing the validity of the clinical study


• Collaborate cross-functionally to the development and review of critical clinical study documents to ensure cross-document consistency e.g. IB versus Clinical Trial Protocol versus Master Informed Consent Form, ...


• Applying the risk-based approach, identify the need to & conduct co-auditing activities / quality visits with DPI and / or CRO representatives


• Provide continuous compliance support by acting as an internal advisor on relevant procedures and regulations to ensure correct interpretation and proper implementation


• Create KQI 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 compound-specific study team and cross-functional Quality peers, assist in driving change to build a culture of compliance throughout the Clinical Development organization


• Provide Audit / CAPA support to the execution of Master Audit Plan executed, assist the DPI business stakeholders to ensure proper CAPA formulation and follow-up


• Provide support to the development / maintenance of QM and ClinDev related Procedural Documents

• University Degree in Sciences or relevant academic background


• 6-8 years’ experience in the clinical setting of the pharmaceutical/biotech industry, including at least 3 years within Clinical Quality Management System & Compliance


• Experience in managing and conducting GCP audits (CROs, TMF, Investigational Sites and CSR)


• Excellence knowledge of GCP. Current and strong working knowledge of GCP, CFR Title 21 and regulatory guidance’s including, ICH quality, clinical, multidisciplinary guidance documents, and 21 CFR Part 11 compliance


• Strong experience in the mechanism of multiple QA vendor’s oversight


• Experience in setting and updating SOPs


• 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


• Fluent in English, French an asset

Debiopharm offers employees:

• 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.