Executive Director, Quality

Role Overview

• Provide ICH/GCP compliance guidance throughout the clinical development life cycle
• 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
• Supervisory responsibility of Quality & Compliance employees
• 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.

Requirements

• Requires 20 years of experience in clinical research with emphasis in Quality Assurance/Compliance
• Working knowledge of GCP/ICH guidelines and FDA regulations and standards
• Supervisory/management experience leading quality personnel
• Bachelor’s degree in a science, healthcare or related field of study
• Availability to travel up to 25% domestically and/or internationally
• Experience leading audits

Tech Stack

• Google Cloud Platform

Benefits

• Health insurance
• Retirement plans
• Paid time off
• Professional development
• Equipment allowances