Debiopharm seeks a Senior Clinical Development Quality Manager to oversee GCP compliance and manage quality oversight for clinical trials in Lausanne, CH. This contractor role runs through May 2027.
The company is looking for a senior professional to lead quality oversight for clinical development projects. The role focuses on maintaining GCP standards, managing study risks, and ensuring the integrity of trial data while supporting stakeholder training and compliance efforts.
Responsibilities
- Offer guidance and support regarding GCP standards to internal teams.
- Track, log, and resolve all GCP-related queries through the dedicated CDQM log.
- Evaluate clinical service providers to verify adherence to regulatory and internal standards.
- Collaborate with internal groups and provider QA teams for continuous monitoring and oversight.
- Assess study risks alongside stakeholders to identify critical quality factors.
- Analyze Key Quality Indicators (KQIs) monthly or quarterly to spot trends and potential risks.
- Share quality insights with stakeholders and help develop mitigation strategies.
- Contribute risk assessments to the audit management process to shape the annual audit plan.
- Prepare teams for internal, regulatory, and site audits as well as service provider reviews.
- Review corrective and preventive actions (CAPAs) to ensure they meet compliance standards.
Requirements
- University degree in Sciences or a related field.
- Four to five years of experience in the pharmaceutical or biotech clinical setting, with at least three years focused on Clinical Quality Management and compliance.
- Proven track record in conducting GCP audits covering internal processes, service providers, trial master files, investigational sites, and clinical study reports.
- Deep understanding of GCP, 21 CFR Title 21, and relevant regulatory guidance, including ICH E6-R3 and 21 CFR Part 11.
- Experience overseeing multiple QA service providers.
- Background in developing and updating standard operating procedures (SOPs).
- Familiarity with computerized system validation.
- Fluent in English; French is a plus.
Nice to have
What the company offers
- Join a workplace built on innovation, collaboration, and impactful results.
- Collaborate with cross-functional teams driving advances in oncology and anti-infective therapies.
- Work in an inclusive, respectful environment certified for equal pay.
- Advance your career in a culture that prioritizes people, purpose, and performance.
- Help shape the future of healthcare through growth and shared expertise.
About the company
Debiopharm operates at the cutting edge of oncology and anti-infective development. The organization fosters an inclusive and respectful environment where innovation and collaboration drive daily operations. As an Equal-Pay certified employer, the company prioritizes people, purpose, and performance to make a meaningful impact in healthcare.
- Core values include innovation, collaboration, and tangible impact.
- Leading developments in oncology and anti-infective treatments.
- Certified for equal pay with an inclusive, respectful workplace.
- Culture emphasizes people, purpose, and performance.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.