Director, Quality

Job Description

Precision for Medicine is seeking a Director, Quality to manage the audit program and support clinical projects, ensuring compliance with regulations and Precision procedures. This role can be performed remotely from various European locations.Responsibilities:

• Manage Quality and Compliance functional activities, including QMS implementation.
• Provide strategic compliance advice for clinical trials.
• Perform ICH/GCP quality reviews/audits.
• Support and mentor Quality & Compliance team members.
• Audit regulatory documents for submission to regulatory authorities.
• Provide ICH/GCP guidance and training.
• Counsel on quality initiatives and ensure quality is maintained cross-functionally.
• Lead system, site, documentation & Trial Master File audits.
• Maintain knowledge of regulations and guidance documents.

Requirements:

• Bachelor’s degree in a science, healthcare, or related field.
• 10 years of experience in clinical research with emphasis in Quality Assurance/Compliance.
• CRO, Pharmaceutical and/or medical device experience.
• Working knowledge of GCP/ICH guidelines and FDA regulations.
• Availability to travel up to 30%.
• Supervisory/management experience.
• Strong leadership, interpersonal, and problem-solving skills.
• Excellent verbal and written communication skills.
• Fluent in English.

The role offers:

• Opportunity to work remotely.
• Chance to lead and mentor a Quality & Compliance team.
• Exposure to a variety of clinical projects and regulatory environments.