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 offers the flexibility to work remotely from various European locations.

Role involves:

• Managing Quality and Compliance functional activities, including QMS implementation.
• Providing strategic compliance advice for 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 and training to clients.
• Leading system, site, documentation & Trial Master File audits.
• Maintaining 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% domestically and/or internationally.
• Supervisory/management experience.
• Strong leadership, interpersonal, and problem-solving skills.
• Excellent verbal and written communication skills.
• Fluent in English.

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.