Director, Quality

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 the UK, Spain, Poland, Slovakia, Hungary, Serbia, or Romania. The Director will work closely with Quality and Compliance staff and Operations, providing strategic compliance advice for clinical trials and performing ICH/GCP quality reviews/audits.

Role involves:

• Managing Quality and Compliance functional activities, including QMS implementation.
• Providing strategic compliance development advice and guidance.
• 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.
• 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.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Fluent in English.

Role offers:

• Opportunity to work remotely within Europe.
• Chance to lead and mentor a Quality & Compliance team.
• Involvement in corporate quality initiatives within Precision for Medicine.