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 is a remote position based in Europe.

The role involves:

• Managing Quality and Compliance functional activities, including implementation of the QMS, SOPs, Training and CAPAs.
• Providing strategic compliance development advice and guidance for optimal conduct of clinical trials.
• Performing ICH/GCP quality reviews/audits.
• Supporting and mentoring Quality & Compliance team members.
• Auditing regulatory documents for submission to regulatory authorities.
• Providing ICH/GCP guidance, auditing advice and training to internal and external clients.
• Leading system, site, documentation & Trial Master File audits.
• Maintaining current 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 and standards.
• Availability to travel up to 30% domestically and/or internationally.
• 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 from various European locations.
• Chance to lead and mentor a Quality & Compliance team.
• Exposure to a wide range of clinical projects and regulatory environments.