P2504 - Clinical Development Quality Lead

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

**Clinical Development Quality Lead (CDQL)**

To ensure excellence in clinical research through proactive quality oversight and GCP compliance. In this key role, you will support stakeholders in vendor qualification, study risk management, team training, and quality coaching while monitoring key risk indicators and trends. Your expertise will help uphold the integrity of clinical trial data, safeguard patient safety, and drive continuous improvement in our clinical development activities. If you are a detail-oriented professional with a passion for quality and collaboration, we invite you to be part of our team.

**Your responsibilities will be but not limited to**:
**1. GCP Support and Oversight**
- Provide GCP support and guidance to clinical development stakeholders.
- Maintain and manage the CDQL GCP query log, ensuring all GCP-related queries are logged, tracked, and resolved promptly.

**2. Quality Event Management**
- Support stakeholders in managing quality events, including investigations and root cause analyses.
- Assist in the development and implementation of CAPAs to address identified quality issues
- **Vendor Qualification and Oversight**
- Responsible for conducting qualification assessment of clinical vendors to ensure compliance with regulatory requirements and internal processes.
- Work closely with stakeholders and vendor QA representatives to ensure effective oversight and continuous monitoring.

**3. Risk Management**
- Review and assess study risks in collaboration with stakeholders.
- Facilitate the identification of study-specific risks and critical data/processes.
- Develop and generate Key Risk Indicators (KRIs) for studies.
- Monitor KRIs on a monthly to quarterly basis through analytics and provide insights to stakeholders.
- Perform trending analyses on KRIs, protocol deviations, and quality events to identify patterns and risks.
- Communicate potential quality issues identified during KRI reviews and support mitigation planning.

**4. Audit and Inspection Readiness**
- Provide input to audit management for risk assessments to support the generation of the audit plan.
- Assist stakeholders in preparing for audits, including site and vendor audits, regulatory inspections, and internal audits.
- Review CAPAs related to audits and inspections to ensure thoroughness and alignment with compliance requirements.

**5. Team Training and Compliance Oversight**
- Perform follow-up on study document training compliance for the Clinical Trial Team (CTT)
- Ensure the CTT team remains up to date with protocol training, and study-specific updates

**6. Continuous Improvement**
- Analyze quality trends from protocol deviations, KRI reviews, audits, and quality events to recommend continuous improvement initiatives.
- Provide training and awareness sessions to stakeholders on GCP compliance, risk management, and quality oversight.

**Requirements**:

- 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

**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