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Metrics and Quality KPI – Leads the tracking and reporting of compliance to the established clinical trial processes. Responsible to analyse, track, report and reinforce adherence to applicable performance measures. Oversees and recommends corrective actions based upon report outputs; ensures that training is developed and implemented as applicable to redirect teams to better Quality KPI scores. Tracks audit and inspection findings, report on results, track trends, generate lessons learned. Ensures effective ongoing operations of the Risk Mitigation Assessment process to improve the rate of compliance of countries to TMO quality standards.
Process Expertise – serves as subject matter expert and input into new SOPs on behalf of TMO, ensures compliance to and adequate training opportunities for new SOPs and Business Guidance. Serves as Lead SME on the monitoring processes as requested. Tracks deviations from Monitoring SOPs and ensures appropriate documentation is filed and corrective actions are taken. Identifies procedural gaps and drives correction with process improvements where applicable. Conducts and supports conduct of vendor qualifications as needed; documents and files qualification evidence appropriately.
Process Compliance – Ensures CAPA commitments are adequate, submitted and completed in a timely manner. Ensures audits and inspections are supported, tracked and outcomes requiring corrective action are managed. Reviews CAPAs and makes appropriate recommendations to keep consistent actions across TMO. Initiates and documents root cause investigations of critical issues in collaboration with Quality Assurance and Clinical Operations. Supports the generation and dissemination of Tactical Memos and Lessons Learned communication in collaboration with monitoring training. Leads the conduct of Trial Master File quality control checks. Ensures TMO compliance with required training by tracking and reporting compliance status for the Global, Regional and Country level organizations. Identifies gaps and assign action where needed to promptly gain compliance.
Inspection Readiness – Leads inspection preparation and execution as well as inspection readiness activities. Supports registration trial readiness by leading the planning and conduct of an annual self-assessment and facilitates spot checks for TMO in conjunction with that being done at the study level by the clinical team. Escalates issues to TMO management and CQA in a timely manner. Ensures that actions required of TMO are appropriately taken. Ensures procedural deficiencies within TMO are corrected and prevented. Liaises with Regional Process Control Managers (rPCM) to ensure local TMO quality is acceptable. Leads inspection response development and implementation as required by the business.
A minimum of 8 years in a R&D regulated environment in a relevant pharmaceutical or health care company, desirable clinical operations experience
Extensive knowledge and experience in ICH-GCP Process Control or ICH-GCP Quality Assurance systems and Health Authority regulations
Demonstrated ability for leading initiatives with cross-functional teams and implementation of recommendations
Experience working in matrix environment and in global teams
College or university degree with significant life science experience. Advanced degree preferably in life sciences is preferred
Fluent in both written and spoken English
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