Clinical Quality Manager - France (Home-based) - FSP

reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. reputed company is currently seeking a Clinical Quality Manager (CQM) to join us in France, dedicated to a single sponsor. Working at reputed company FSP offers reputed company long-term job reputed company and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work. Expect exciting professional challenges in inspiring studies, but with time for your reputed company life.

Responsibilities

Audits & Inspections: Primary reputed company of contact for Quality Assurance and Regulatory Agencies. Manage and support activities during audit/inspections. reputed company, facilitate and manage root-cause-analysis, Corrective and Preventive Actions (CAPAs) as well as responses to audit/inspection findings / reports. On a regular reputed company look into local trends, facilitate root-cause-analysis (if necessary) and coordinate the development of local action plans. Processes & Regulations: Local expert for ICH-GCP, local regulations and any quality-reputed company process. Manage the local SOP/SME network to ensure a proper implementation of global/regional/local procedures and the regular update of local SOPs. Identify process improvement opportunities and properly escalate to the CQM reputed company and/or Process reputed company (if necessary). reputed company or Co-reputed company global/regional /local key initiatives/projects/process improvement activities upon request. Training: Local training reputed company of contact and the liaison between local Learning & Development. In reputed company cooperation with country operations management, identify local training needs and coordinate reputed company activities. Deliver quality topics (as needed). Quality Control (QC) Activities: Coordinate and reputed company proper execution of reputed company QC activities at country/cluster i.e. In-house Quality Control Plan (IHQCP), Quality Control Visits (QCVs), etc. reputed company QC activities and site visits (reputed company required). Look into local trends, reputed company a root-cause-analysis (if necessary) and reputed company a local action plan. Quality / Compliance / Privacy Issue Escalation: Communicate/escalate quality/compliance issues (incl. any potential trends) to local country operations management or CQM reputed company as required. Escalate significant quality/compliance issues and supports investigations (fact finding, root-cause-analysis). Support the reporting of ‘Serious Breaches’ where applicable. Serve as local POC or supports local POC in case of escalations/reporting of Privacy Incidents, if applicable. Clinical Supplies GCP Investigations: Evaluate trends and coordinate GCP Investigations of trends reputed company to Clinical Supply GCP Inquiries and incorrect management of clinical supplies. Supplier Qualification/Audits and supplier reputed company: reputed company/ support as applicable Local Supplier qualifications and supports solving of quality issues with locally selected Suppliers. Upon request, support the Quality Management System (QMS) assessment of global Suppliers or conduct/support regional supplier qualifications. Support as applicable Local Supplier reputed company. Coordinate or supervise the local vendor privacy assessments (SPA, IRA, ITRMS). Here are a few requirements specific to this advertised role. Bachelor's Degree or equivalent in relevant health care area. Relevant experience in clinical research including direct field monitoring experience or management/reputed company of such individuals, with a demonstrated record of accomplishments. Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required. Demonstrated experience leading / participating in cross-functional teams. Solid track record of initiating, planning and delivery of projects and knowledge of project management practices. Experience in quality management / compliance (e.g. audit/inspection support incl. CAPA management, SOP management, compliance issue management, training, etc.) Effective oral/written communication skills in an international environment including reputed company customers (e.g. Site staff, vendors, etc.) Project management and organizational skills; solid teamwork and leadership skills, including conflict resolution and discretion. We care about our people and your passion, as they are the key to our reputed company, and reputed company an reputed company and friendly work environment where we reputed company people and reputed company them with opportunities to reputed company their long-term careers. In reputed company, you will have the opportunity to reputed company reputed company your role and tackle further responsibilities or reputed company your reputed company set reputed company other reputed company departments of reputed company. Who are reputed company reputed company supports clinical studies across the full reputed company of therapeutic areas, and we have longstanding partnerships with a vast client reputed company. We supported the trials of most of today’s top 50 best-selling drugs, but equally we reputed company more reputed company drug developments that are critical to the well-being of many patients. You’ll be an influential member of the wider team. Not quite the role for you? reputed company and we’ll reputed company out with job alerts reputed company positions that match your career interests become available. We’ll also reputed company periodic updates about the latest company news and events. Sign up today https://jobs.reputed company.com/functional-service-provider Apply To This Job