Clinical and Preclinical Quality Director

Summary

The Clinical and Preclinical Quality Director (CQD) will lead the development, implementation, and communication of high-quality standards to ensure the delivery of global clinical studies. With a focus on proactive quality management, this role supports Clinical Development by driving quality excellence, safeguarding data integrity, and enabling R&D objectives for the submission of new therapies. The CQD plays a key role in ensuring adherence to the Quality System and execution of RDQA Quality System Excellence, including CAPA, Change Management, Quality Risk Management, and Documentation Standards.

As the primary CQA contact for regulatory GCP inspections, the CQD will lead inspection readiness and execution, while supporting a broad range of GxP inspections across sponsors and sites. This role provides expert technical quality guidance and consultation to R&D colleagues and Development Operations business partners.

This position reports directly to the Head of Quality at ARTBIO.

• Ensure a continuous state of compliance with global and local regulations, ARTBIO policies, and procedures – driving inspection readiness for clinical trials and investigations inspections to deliver strong business outcomes while positioning ARTBIO for future success.
• Develop and implement innovative quality strategies for clinical and preclinical programs by collaborating with cross-functional stakeholders. Provide timely and effective responses to compliance issues, audits, and inspections impacting development operations, and lead reportability decisions for serious breaches across countries.
• Develop and lead initiatives to proactively assess quality risks in clinical and preclinical activities, including data integrity issues, and drive risk identification, mitigation, and prevention. Facilitate key quality improvements and innovation while promoting a culture of continuous regulatory preparedness.
• Advise study teams on procedural frameworks, including global clinical processes, procedural documents, and applicable Quality & Compliance manual documents, in line with international guidelines, such as ICH-GCP, industry standards, and local regulations.
• Provide expert guidance on clinical trial regulations, monitor regulatory changes, and ensure local teams and processes remain current and compliant.
• Plan and conduct quality control activities in line with the annual quality plan, including performing accompanied site visits. Perform any required QC visits / QC activities.
• Regularly reviews protocol deviations and ensures timely reporting of quality issues to local Authorities and in ARTBIO’s internal systems, in accordance with QMS processes.
• Share learnings from audits and inspections with staff and across Clinical and Quality networks, and communicate global and regional insights to local teams.
• Serve as a key contact in the evaluation and management of fraud/poor quality cases, and communicate with Quality Assurance (QA), and management, as required.
• Actively leads the conduct of GCP / Clinical investigations of inspections, providing expert guidance in strategy and support to enable successful inspections and high-quality CAPAs.
• Support the implementation of general QA, clinical, and preclinical global procedures and systems by providing review input and QA approval of global procedural documents by request.

• Bachelor’s degree, preferably in a life science discipline.
• Minimum 10 years of relevant experience in clinical and preclinical Quality, including significant experience in a GCP-regulated environment with clinical trial management and investigator site compliance
• ICH-GCP, ISO 9001, or CCRP certifications preferred.
• GMP knowledge preferred.
• Excellent working knowledge of international ICH-GCP guidelines and relevant local regulations, GLP regulations, and preclinical expectations.
• Strong understanding of the drug development process and related GXP activities.
• Solid understanding of the skills and knowledge required for the successful delivery of a clinical study (e.g., ICH-GCP, study management, site management, and monitoring).
• Ability to learn…