Responsibilities:
– Provide GCP support and guidance to clinical development stakeholders
– Maintain and manage the GCP query log, ensuring all GCP-related queries are logged, tracked, and resolved promptly
– 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
– Conduct 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
– Review and assess study risks in collaboration with stakeholders
– Facilitate the identification of study-specific risks and critical data/processes
– 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
– Perform follow-up on study document training compliance for the Clinical Trial Team
– Ensure the Clinical Trial Team remains up to date with protocol training and study-specific updates
Qualifications:
– 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)
– Excellent knowledge of GCP, with current and strong working knowledge of GCP, CFR Title 21 and regulatory guidance 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
– Excellent communication skills in English
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 an organization where innovation, people and entrepreneurship are the fundamental keys to success
– Equal-Pay certified employer ensuring the same opportunities for all employees