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 crucial for maintaining the quality and integrity of clinical trials.

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.
• Strong leadership, interpersonal, and problem-solving skills.
• Fluent in English.

The role offers:

• A fully remote position within Europe.
• Opportunity to work with a leading organization in precision medicine.
• Chance to enhance and ensure quality is assessed and maintained cross-functionally.