Remote Associate Director, GCP Quality and Compliance

Summary

Join us today as an Associate Director, GCP Quality and Compliance to support the audit program and clinical projects, ensuring compliance with regulations and Precision procedures.

Requirements

• Requires 8-10 years of experience in clinical research or pharmaceutical development with emphasis in Quality Assurance/Compliance or equivalent relevant experience and/or demonstrated competencies
• Working knowledge of GCP/ICH guidelines and FDA regulations and standards
• Bachelor’s degree in a science, healthcare or related field of study

Responsibilities

• Work closely with the Quality and Compliance management/staff and Operations to provide strategic compliance development advice and guidance for optimal conduct of clinical trials
• Perform ICH/GCP quality reviews/audits to ensure overall compliance with applicable regulations
• Lead the oversight of a Quality Management Systems inclusive of SOPs, Training and CAPAs
• 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
• 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

Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance and disability benefits
• Parental leave
• Paid time off for sick leave and vacation