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 is based in Europe and can be fully remote from various European locations. The Director will work closely with the Quality and Compliance staff and Operations to provide strategic compliance development advice and guidance for optimal conduct of clinical trials.Responsibilities:

• Manage Quality and Compliance functional activities, including implementation of the QMS, inclusive of SOPs, Training and CAPAs.
• Perform ICH/GCP quality reviews/audits to ensure overall compliance with applicable regulations.
• Support and mentor Quality & Compliance team members.
• Audit regulatory documents for submission to the FDA and global regulatory authorities.
• Provide ICH/GCP guidance, auditing advice, and training to internal and external clients.
• Lead system, site, documentation & Trial Master File audits.
• Participate in leading, maintaining, and executing the corporate quality initiatives.

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.
• Fluent in English.

The role offers:

• A fully remote work opportunity within Europe.
• The chance to work with a leading company in precision medicine.
• Opportunity to enhance quality is assessed and maintained cross-functionally