Full-Time Director Quality Mgmt & Compliance

Director, Quality Management & Compliance

Job Overview:

• Leads and manages the QA team and business partners for Quality Management System.
• Provides input into the global audit program, identifying risks and determining audit types/frequency.
• Oversees audits, reviews, and reporting.
• Manages Escalated Issues Management (review, approval, tracking, and closure of Quality Issues, CAPAs, and Deviations).
• Mentors quality professionals, ensuring deliverables meet Ergomed standards, regulatory requirements, and client expectations.
• Develops and drives continuous process improvements via specific projects.
• Conducts training and contributes to policy decisions.
• Acts as key contact for sponsor audits and leads preparation/hosting.
• Provides guidance for Root Cause and CAPA plan analysis.
• Interprets regulatory requirements and guidelines (GxP, clinical research).
• Participates in system risk assessments and implementation (e.g., IT systems).
• Writes and reviews Quality Assurance and other CRO departmental controlled documents.

Qualifications:

• Degree in Life Science related subject.
• CRO experience with a focus on GCP Quality.
• Risk-Based Quality experience.
• Drug development and regulatory knowledge.
• Strong communication, management, and collaboration skills.
• Cross-functional team leadership ability.
• Strong organizational, presentation, documentation, and interpersonal skills.
• Problem-solving and decision-making skills.
• Strong customer focus.

What is the last date for applying to the job?

Which countries are accepted for this remote job?