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 locations including the UK, Spain, Poland, Slovakia, Hungary, Serbia, or Romania. 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:

• Managing Quality and Compliance functional activities, including implementation of the QMS, inclusive of SOPs, Training and CAPAs.
• 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.
• Participating 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.
• Fluent in English language.

The role offers:

• A fully remote work opportunity within Europe.
• Opportunity to work with cross functional groups and management under challenging situations