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 various European locations.She will manage Quality and Compliance functional activities, provide strategic compliance development advice, and perform ICH/GCP quality reviews/audits. She will also support and mentor Quality & Compliance team members, audit regulatory documents, and provide ICH/GCP guidance and training.Role involves:

• 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

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%
• Supervisory/management experience
• Strong leadership, interpersonal, and problem-solving skills
• Excellent verbal and written communication skills
• Excellent computer skills
• Fluent in English

Role offers:

• Managing Quality and Compliance functional activities, including implementation of the QMS, inclusive of SOPs, Training and CAPAs
• Working closely with the Quality and Compliance staff and Operations to provide strategic compliance development advice and guidance for optimal conduct of clinical trials and performs ICH/GCP quality reviews/audits to ensure overall compliance with applicable regulations.
• Supporting and enhancing Precision’s Corporate Compliance functions and facilitate business development and proposals for these areas as the need arises, including bid defense meetings and project kick-off meetings
• Leading system, site, documentation & Trial Master File audits to ensure compliance with internal SOPs/project plans and industry standards
• Participating in leading, maintaining and executing the corporate quality initiatives within Precision for Medicine