Clinical Quality Manager – FSP

Role Overview

• Primary point of contact for Quality Assurance and Regulatory Agencies.
• Manage and support activities during audit/inspections.
• Perform, facilitate and manage root-cause-analysis, Corrective and Preventive Actions (CAPAs) as well as responses to audit/inspection findings / reports.
• On a regular basis look into local trends, facilitate root-cause-analysis (if necessary) and coordinate the development of local action plans.
• Local expert for ICH-GCP, local regulations and any quality-related 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 Lead and/or Process Owner (if necessary).
• Lead or Co-Lead global/regional/local key initiatives/projects/process improvement activities upon request.
• Local training point of contact and the liaison between local Learning & Development.
• In close cooperation with country operations management, identify local training needs and coordinate related activities.
• Deliver quality topics (as needed).
• Coordinate and oversee proper execution of all QC activities at country/cluster i.e. In-house Quality Control Plan (IHQCP), Quality Control Visits (QCVs), etc.
• Perform QC activities and site visits (when required).
• Communicate/escalate quality/compliance issues (incl. any potential trends) to local country operations management or CQM Lead as required.
• Support the reporting of ‘Serious Breaches’ where applicable.
• Evaluate trends and coordinate GCP Investigations of trends related to Clinical Supply GCP Inquiries and incorrect management of clinical supplies.
• Lead/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.
• Coordinate or supervise the local vendor privacy assessments (SPA, IRA, ITRMS).

Requirements

• Bachelor's Degree or equivalent in relevant health care area.
• Relevant experience in clinical research including direct field monitoring experience or management/oversight 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 internal and external customers (e.g. Site staff, vendors, etc.)
• Project management and organizational skills; solid teamwork and leadership skills, including conflict resolution and discretion.

Tech Stack

• Google Cloud Platform

Benefits

• Health insurance
• Professional development opportunities