Quality Assurance Manager

Position Summary:

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

• Quality Assurance representative for the Winston-Salem, NC location of Precision for Medicine
• Collaborate with operational and quality staff in other Precision locations to execute harmonization plans for global processes and procedures to be implemented and maintained
• Responsible foraligning global practices, promoting improvement, leading and maintaining compliance, and measuring and reporting on performance and effectiveness through established metrics and KPIs
• Host client, external regulatory agency, and notified body assessments and inspections (example: FDA, CAP). Review and participate in issues and/or decisions related to assessments
• Lead inspection readiness activities
• Manage the Quality System and support the quality functions of all critical operations
• Review and approve quality system activities (including but not limited to Deviation, Non-Conformances, Customer Complaints, CAPA, Audits, Validation, Qualification, Equipment, Review and Disposition of final product/data)
• Contribute to the evaluation and mitigation of program risks and escalation of potentially significant quality issues
• Advise staff to help meet established schedules or resolve technical or operational problems
• Plan, promote and organize training activities related to operations, quality assurance, and compliance
• Estimate and administer budget schedules and performance standards
• Maintain an up-to-date knowledge in the techniques of quality and in the company products/services and process technologies
• Prepare and lead management reviews of the quality management system for the site and provide inputs to global management review
• Maintains up-to-date knowledge of regulations and applicable worldwide standards and requirements
• Coordinate and/or ensure annual training for HIPPA, Bloodborne Pathogens, Hazard Communication, and Ergonomics, and Quality Compliance
• Maintain the biological and chemical waste management programs to ensure compliance to Local, State and DOT regulations
• Schedule and manage the review of computer systems, process and equipment validations and re-validation in accordance with established Company policy. Complete validation protocols and reports and ensure compliance with all relevant Quality Standards and regulatory requirements
• Work in conjunction with purchasing department to develop supplier partnership opportunities and ensure supplier qualifications meet current Quality Standards and regulatory requirements
• Other duties as assigned

Qualifications:

Minimum Required:

• Bachelor’s Degree in Physical, Biological Sciences, or technical/scientific field
• 6 years of experience as a Quality professional in the biotechnology or life science, regulated environment

Other Required:

• Excellent knowledge of medical research processes, laboratory testing protocols, companion diagnostics, and safety requirements
• Strong understanding of medical data collection, record keeping, and reporting requirements
• Experience interpreting and complying with world-wide cGxPs with an emphasis on GMP, GCP, GLP, GCLP, and blood establishments
• Experience auditing and interacting and relationship building with the public (vendors and clients)
• Proficiency with common computer applications such as MS Office and other relevant industry computerized systems
• Extended business hours may be necessary in order to meet the business demands
• This position will require occasional domestic or international travel, including overnight stays (up to 20%)
• Must be able to read, write, speak fluently and comprehend the English language

Preferred:

• Master’s degree in Physical, Biological Sciences, or technical/scientific field
• ASQ or SQA certification desirable (obtain certification within first year)