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 involves managing quality and compliance activities, providing strategic compliance advice, and performing ICH/GCP quality reviews/audits. The Director will also support and mentor Quality & Compliance team members, audit regulatory documents, and provide ICH/GCP guidance and training.

• Managing Quality and Compliance functional activities
• Providing strategic compliance development advice
• Performing ICH/GCP quality reviews/audits
• Supporting and mentoring Quality & Compliance team members
• Auditing regulatory documents
• Providing ICH/GCP guidance and training
• Leading system, site, documentation & Trial Master File audits

Requirements for this position include a Bachelor’s degree in a science, healthcare, or related field, along with 10 years of experience in clinical research with an emphasis in Quality Assurance/Compliance. A working knowledge of GCP/ICH guidelines and FDA regulations is essential, as is the ability to travel up to 30%. Strong leadership, interpersonal, and problem-solving skills are also required.

• 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

Precision for Medicine offers the opportunity to work remotely from various European locations and contribute to corporate quality initiatives. The role also involves enhancing corporate compliance functions and participating in business development activities.

• Remote work opportunity
• Contribution to corporate quality initiatives
• Enhancement of corporate compliance functions
• Participation in business development activities