Director, Quality

Precision for Medicine is hiring Director, Quality based in Europe. The position can be covered fully remotely from one of our European locations: UK, Spain, Poland, Slovakia, Hungary, Serbia or Romania.

Position Summary:

The Director, Quality manages the audit program and supports clinical projects to ensure compliance with regulations and Precision procedures.

Essential functions of the job include but are not limited to:

• Manage Quality and Compliance functional activities, including implementation of the QMS, inclusive of SOPs, Training and CAPAs
• Work 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.
• Initiate the process of follow-up when suspicion of suspected scientific misconduct/serious non- compliance
• Support and mentor Quality & Compliance team members
• Audit regulatory documents for submission to the Food and Drug Administration (FDA) and global regulatory authorities (e.g. MHRA)
• Provide ICH/GCP guidance, auditing advice and training to internal and external clients
• As part of the Management Team help counsel on and direct quality initiatives to Provide ICH/GCP compliance guidance throughout the clinical development life cycle enhance/ensure quality is assessed and maintained cross-functionally
• Support and enhance 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
• Lead system, site, documentation & Trial Master File audits to ensure compliance with internal
• SOPs/project plans and industry standards
• Review/audit documents intended for submission to the FDA to assure compliance with regulatory standards
• Build upon the current QMS in establishing additional company standards and metrics to ensure the highest quality of services provided to clients
• Participate in leading, maintaining and executing the corporate quality initiatives within Precision for Medicine
• Maintains current knowledge of regulations and guidance documents, providing expert analysis to project teams.
• Other duties as assigned

Qualifications:

• Bachelor’s degree in a science, healthcare or related field of study or equivalent
• Requires 10 years of experience in clinical research with emphasis in Quality Assurance/Compliance or equivalent relevant experience and/or demonstrated competencies
• 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

Skills:

• Strong leadership skills, excellent interpersonal and problem-solving skills, strong verbal and written communication, excellent computer skills
• Demonstrates mastery knowledge of GCP/ICH guidelines, FDA regulations and Precision SOPs - Motivates other members of the project team to meet timelines and project goals
• Ability to review and evaluate clinical data, with advanced proficiency in Microsoft Word, Excel, and PowerPoint, and some knowledge of Access or similar database
• Understands financial management to review proposals and budgets
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment
• Must possess a customer service demeanor; demonstrate collaboration and flexibility, teamwork, and keen attention to detail
• Ability to work with cross functional groups and management under challenging
• situations
• Ability to prioritize work and handle multiple and/or competing assignments
• Fluent in English language, with excellent verbal and written communications skills

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