Quality Lead

ProPharma is seeking a Quality Lead to drive positive change and process improvement in the assigned region. The Quality Lead will perform quality activities as outlined in ProPharma's Quality Policy and procedures, and develop, manage, and execute quality management processes to ensure quality standards are maintained and compliant with regulatory requirements.

Requirements

• Maintains awareness of and ensures adherence to applicable SOPs/controlled documents, regulations, guidelines, and all types of client agreements.
• Serves as control point for SOPs/controlled documents and Quality Management System documents.
• Contributes to the creation of controlled documents, such as SOPs and Work Instructions.
• Supports the delivery of the internal quality program, including quality assurance and quality control.
• Assists in investigating service complaints and deviations, identifying root cause and CAPAs and communicating these to relevant stakeholders.
• Collaborates with Operational and Client Services Managers to support preparation for client audits and regulatory inspections.
• Acts as host or supports client audits and regulatory inspections as needed and acts as SME for quality topics.
• Develops responses to CAPAs arising from client audits and regulatory inspections at ProPharma, with support from Operations Managers, Client Services and Global Quality, and tracks to completion and closure.
• Participates in relevant client operational meetings as directed by Management.
• Supports the Quality Manager in the Regional Quality Committee meeting and acts as a regional representative in the Global Quality Committee.
• Proactively identifies improvement opportunities to support the continuing development of ProPharma