Director of Quality - Remote

Overview

The Director, Quality manages the audit program and supports clinical projects to ensure compliance with regulations and Precision procedures, with the flexibility to work remotely from various European locations.

In Short

• Manage Quality and Compliance functional activities.
• Provide strategic compliance development advice for clinical trials.
• Initiate follow-up processes for suspected misconduct.
• Mentor Quality & Compliance team members.
• Audit regulatory documents for submission to authorities.
• Provide guidance and training on ICH/GCP standards.
• Lead audits to ensure compliance with internal SOPs and industry standards.
• Build upon the current Quality Management System (QMS).
• Maintain current knowledge of regulations and provide expert analysis.
• Participate in leading corporate quality initiatives.

Requirements

• Bachelor’s degree in a science or related field.
• 10 years of experience in clinical research with a focus on Quality Assurance.
• Experience in CRO, Pharmaceutical, or medical device sectors.
• Knowledge of GCP/ICH guidelines and FDA regulations.
• Availability to travel up to 30% domestically/internationally.
• Supervisory/management experience.

Benefits

• Opportunity to work remotely from various European locations.
• Collaborative work environment.
• Professional development opportunities.
• Competitive salary and benefits package.