Director, Quality Assurance

Responsibilities

• Plan and direct resources and activities of the quality and compliance functions across all global facilities
• Provide oversight to site-specific quality leadership teams
• Lead process improvement initiatives and align global quality systems across sites
• Oversee Global Quality Management Systems supporting laboratories, supplier qualification, and clinical trials
• Support quality functions related to FDA QSR, IVDD/IVDR, ISO 13485, and ISO 15189
• Manage release of all products and results for commercial companion diagnostic products
• Support pre-market activities including design control and risk management for medical devices
• Host and support external regulatory agency, client, and notified body inspections (CLIA, CAP, FDA, ISO, EMA)
• Manage process and equipment validations and re-validations
• Maintain robust CAPA, nonconformance, and QMS electronic documentation systems

Requirements

• Bachelor’s degree in Physical Sciences, Biological Sciences, or a technical/scientific field
• 10-12 years of experience in a regulated life science environment
• 5 years of supervisory experience
• Experience with medical device pre- and post-market activities
• Proficiency in interpreting CLIA, CAP, GLP, FDA QSR, ISO 15189, and ISO 13485
• Ability to lead and manage a global quality team
• Ability to travel up to 30% internationally
• Relevant industry certifications

Preferred Qualifications

• Experience auditing and building relationships with regulators, vendors, and clients
• Proficiency with MS Office and industry-specific computerized systems

About the Company

Precision Medicine Group provides specialized services to support the development and commercialization of precision medicines.