Mission
The Clinical Development Quality Manager (CDQM) is responsible for ensuring quality oversight across clinical development activities and supporting the maintenance of GCP compliance. This role supports stakeholders in vendor qualification, study risk management, quality oversight, team training compliance, and coaching as needed. Responsibilities include monitoring Key Quality Indicators (KQIs), analyzing trends in quality events, ensuring protocol adherence and providing support for quality events, audits, and corrective and preventive actions (CAPAs). The CDQM ensures proactive identification and mitigation of risks to maintain the integrity of clinical trial data and protect patient safety.
Main responsibilities
GCP Support and Oversight :
- Provide GCP support and guidance to clinical development stakeholders.
- Maintain and manage the CDQM GCP query log, ensuring all GCP-related queries are logged, tracked, and resolved promptly.
Vendor Qualification and Oversight :
- Responsible for conducting qualification assessment of clinical service providers to ensure compliance with regulatory requirements and internal processes.
- Work closely with internal stakeholders and service providers QA representatives to ensure effective oversight and continuous monitoring.
Risk Management :
- Review and assess study risks in collaboration with stakeholders.
- Facilitate the identification of study-specific risks and critical to quality factors.
- Monitor KQIs on a monthly to quarterly basis through analytics and provide insights to stakeholders.
- Perform trending analyses on KQIs, and quality events to identify patterns and risks.
- Communicate potential quality issues identified during KQI reviews and support mitigation planning.
Audit and Inspection Readiness :
- Provide input to audit management for risk assessments to support the generation of the audit plan.
- Support stakeholders in preparing for audits, including site and service provider’s audits, regulatory inspections, and internal audits.
- Review CAPAs related to audits and inspections to ensure thoroughness and alignment with compliance requirements.
Quality Events and Deviations Management :
- Support stakeholders in managing quality events and deviations, including investigations and root cause analyses.
- Assist in the development and implementation of CAPAs to address identified quality events and deviations.
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.
Continuous Improvement :
- Analyze quality trends from KQI 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
Profile
- University Degree in Sciences or relevant academic background
- 4-5 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 (Internal processes, Service Providers, TMF, Investigational Sites and CSR)
- Excellent knowledge of GCP. Current and strong working knowledge of GCP, CFR Title 21 and regulatory guidance’s including, ICH E6-R3 implementation, multidisciplinary guidance documents, and 21 CFR Part 11 compliance
- Strong experience in the mechanism of multiple QA service provider’s oversight
- Experience in setting and updating SOPs
- Knowledge of computerized systems validation
- Rigor, adaptability, proactivity 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
What we Offer
· Being part of a company where innovation, collaboration, and impact aren’t just values — they’re how we work every day
· Partner with teams across disciplines, at the forefront of oncology and anti-infective development
· An inclusive and respectful workplace — proud to be Equal-Pay certified
· Grow in a culture that values people, purpose, and performance
· A chance to grow, share, and shape the future of healthcare
What to Expect in the Recruitment Process:
If your application is selected, you’ll be invited to interviews with Talent Acquisition and the Hiring Manager via Teams, followed by a panel interview and reference checks. Communication is handled via Workable—check your spam folder for emails from *@outbound.workable.com.
We do not accept unsolicited applications from agencies or recruiters.
Skills Required
- University degree in sciences or relevant academic background
- 4-5 years' experience in clinical pharmaceutical/biotech setting, including ≥3 years in Clinical Quality Management System & Compliance
- Experience managing and conducting GCP audits (internal processes, service providers, TMF, investigational sites, CSR)
- Strong working knowledge of GCP, 21 CFR (Title 21), ICH E6-R3 implementation and related regulatory guidance
- Experience overseeing multiple QA service providers
- Experience setting and updating SOPs
- Knowledge of computerized systems validation
- Experience monitoring Key Quality Indicators (KQIs) and performing trending analyses
- Experience supporting audit readiness, inspections, CAPA development and root cause analysis
- Rigor, adaptability, proactivity, organization, and focus on continuous improvement
- Fluent in English; French is an asset
What We Do
Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to develop tomorrow's standard of care to cure cancer & infectious diseases and improve patient quality of life.
