Quality Systems Manager - Monogram Biosciences

Monogram Biosciences (part of LabCorp’s Specialty Testing Group) is seeking a Quality Systems Manager to join its team in South San Francisco! The Quality Manager will be a key position to Monogram's development of a sustainable and robust Companion Diagnostic (CDx) business. This includes Single-Laboratory-Use assay development, Manufacturing, and CLIA laboratory operations that will support all phases of CDx product development and commercialization in the US and select markets outside of the US.

The Quality Systems Manager will be responsible for providing quality oversight and leadership for Monogram's FDA compliant Quality Management System (QMS) and Companion Diagnostic (CDx) Assay development efforts.  Reporting to the Director of QA, this position will require routine coordination with multidisciplinary functional and product-specific project teams dedicated to building and improving Monogram's QMS while providing products & services to our Pharma partners.  The ideal candidate will have experience in implementing a Part 820 QSR Quality System.  

Responsibilities:

• Develop, implement and provide continuous improvement of paper and electronic quality systems in compliance with QSR, CLIA, GxP and other applicable regulations and guidelines

• Represent QA in functional team meetings; provides guidance and recommendations in alignment with regulatory requirements
• Maintain updated and relevant knowledge of the QSR, GxP landscape, regulations, and guidelines
• Design, implement and maintain nonconformance and CAPA management systems. Identify and classify nonconformances, deviations, OOS, OOT; collaborate with other departments for investigations and determination of root cause
• Establish a formal change control management system for GxP related activities. Review and approve change controls related to the implementation or revision of process, method, and/or equipment changes
• Implement and manage QSR compliant training programs
• Maintain equipment files, approve IQ/OQ/PQ protocol and reports, and ensure all applicable documentation is archived
• Author and revise standard operating procedures
• Identify opportunities for improvement, and drive continuous improvement initiatives
• Manage trends and reports key quality metrics to the leadership team
• The position will be expected to supervise approximately 1-3 analysts

Requirements:

• B.S./B.A. degree in a scientific discipline
• Quality professional with 6-8 years of hands-on experience with increasing responsibility in a Quality function
• Minimum 2 years of previous supervisory experience required
• Hands-on experience in implementing a Part 820 QSR-compliant electronic/paper based quality systems in a GxP environment, and direct experience with FDA and other health authority inspections
• Extensive knowledge of US GxP compliance regulations and industry practices, as well as EU GxP requirement
• Experience coordinating quality management reviews and quality metrics exercises

About Monogram:

Monogram Biosciences, Inc. (a wholly-owned subsidiary of LabCorp), is a leader in developing and commercializing innovative diagnostic products to help guide and improve the treatment of HIV, HCV, and other viral illnesses, as well as cancer and other diseases. Monogram’s services enable health care providers to optimize treatment regimens for their patients. Monogram also supports pharmaceutical companies in developing new and improved antiviral therapeutics and vaccines and targeted cancer therapeutics. Located in South San Francisco, Monogram provides an innovative and flexible work environment, where you will have the opportunity to be part of pioneering new diagnostics technologies.