Clinical Development Quality Lead (CDQL)
For our Quality organization based at our Headquarters in Lausanne, Debiopharm is seeking a Clinical Development Quality Lead (CDQL) to ensure excellence in clinical research through proactive quality oversight and GCP compliance. You will support stakeholders in vendor qualification, study risk management, team training, and quality coaching while monitoring key risk indicators and trends. This role helps uphold the integrity of clinical trial data, safeguard patient safety, and drive continuous improvement in our clinical development activities.
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
3. Vendor Qualification and Oversight
* Conduct qualification assessment of clinical vendors to ensure regulatory compliance and alignment with internal processes
* Work with stakeholders and vendor QA representatives to ensure effective oversight and continuous monitoring
* Review and assess study risks in collaboration with stakeholders
* Identify study-specific risks and critical data/processes
* Develop and monitor Key Risk Indicators (KRIs) for studies
* Perform monthly to quarterly KRIs analytics and provide insights to stakeholders
* Conduct 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
* Contribute to risk assessments for audit planning
* Assist stakeholders in preparing for audits (site, vendor, regulatory inspections, and internal audits)
* Review CAPAs related to audits and inspections to ensure thoroughness and compliance
5. Team Training and Compliance Oversight
* Follow up on study document training compliance for the Clinical Trial Team (CTT)
* Keep the CTT up to date with protocol training and study-specific updates
* Analyze quality trends from protocol deviations, KRIs, audits, and quality events to recommend improvements
* Provide training and awareness sessions to stakeholders on GCP compliance, risk management, and quality oversight
6. Continuous Improvement
* Analyze quality trends to suggest continuous improvement initiatives
* Support efficiency and continuous improvement through pragmatic approaches
Requirements
* University Degree in Sciences or relevant academic background
* 6-8 years in the clinical setting of the pharmaceutical/biotech industry, including at least 3 years in Clinical Quality Management System & Compliance
* Experience in managing and conducting GCP audits (CROs, TMF, Investigational Sites, CSR)
* Excellent knowledge of GCP and regulatory guidance including 21 CFR Part 11; familiarity with ICH quality and related guidance
* Experience with QA vendor oversight, SOPs, and computerized systems validation
* Strong organization, adaptability, and strategic thinking with emphasis on efficiency
* Fluent in English; French is an asset
Benefits
* International, dynamic environment with a long-term vision
* Cross-functional collaboration at the forefront of oncology and antibacterial research
* Exposure to a wide variety of areas within clinical development and the pharmaceutical industry
* Opportunities for innovation, growth, and equal-pay practices
The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. Unsolicited resumes from external recruiters are not accepted.
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance
Industries: Pharmaceutical/Biotech
Submission of unsolicited resumes does not create any obligation on Debiopharm.
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