Director, Quality

Summary

Join Precision for Medicine as their Director, Quality, a fully remote position based in Europe (UK, Spain, Poland, Slovakia, Hungary, Serbia, or Romania). Manage the audit program, support clinical projects to ensure compliance, and implement the Quality Management System (QMS). Collaborate with staff and operations to provide compliance guidance for clinical trials and conduct quality reviews/audits. Initiate follow-up for suspected misconduct and mentor team members. Audit regulatory documents for submission to the FDA and other global authorities. Provide ICH/GCP guidance and training. Counsel on quality initiatives, support corporate compliance functions, and participate in business development. Lead system, site, and document audits. Review documents for FDA submission. Build upon the current QMS and participate in corporate quality initiatives. Maintain current knowledge of regulations and provide expert analysis. Other duties as assigned.

Requirements

• 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
• 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

Responsibilities

• 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

Benefits

The position can be covered fully remotely from one of our European locations: UK, Spain, Poland, Slovakia, Hungary, Serbia or Romania