Director, Quality

Job Description

Precision for Medicine is seeking a Director of Quality to manage the audit program and ensure compliance with regulations and Precision procedures. This role involves strategic compliance development advice and guidance for clinical trials.About Precision for MedicinePrecision for Medicine is a leading clinical research organization.Responsibilities:

• 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 to ensure overall compliance with applicable regulations.
• Supporting and mentoring Quality & Compliance team members.
• Auditing regulatory documents for submission to the FDA and global regulatory authorities.
• Providing ICH/GCP guidance, auditing advice and training to internal and external clients.
• Leading system, site, documentation & Trial Master File audits.

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.
• Fluent in English.

The role offers:

• A fully remote position within Europe (UK, Spain, Poland, Slovakia, Hungary, Serbia or Romania).
• Opportunity to lead and mentor a Quality & Compliance team.
• Chance to enhance Precision’s Corporate Compliance functions.