Director, Quality

Job Description

Precision for Medicine is seeking a Director, Quality to manage the audit program and ensure compliance with regulations and Precision procedures. This role is crucial for maintaining the quality and integrity of clinical projects.

Responsibilities:

• Managing Quality and Compliance functional activities, including implementation of the QMS, SOPs, Training, and CAPAs.
• Providing strategic compliance development advice and guidance for clinical trials.
• 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, auditing advice, and training to internal and external clients.
• Leading system, site, documentation & Trial Master File audits.
• Participating in 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.
• Excellent verbal and written communication 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 across functional areas.