Quality Manager

About Us CSI Laboratories, a Fulgent Genetics Company, is a nationally recognized cancer testing and diagnostics laboratory experienced in helping pathologists and oncologists diagnose and treat cancer patients. Founded in 2011, our parent entity, Fulgent Genetics, has evolved into a premier full-service genomic testing company built around a foundational technology platform. Through our diverse testing menu, Fulgent is focused on transforming patient care in oncology, anatomic pathology, infectious and rare diseases, and reproductive health.

We believe that by providing a wide range of effective, flexible testing options in conjunction with best-in-class service and support, we can redefine the way medicine is managed for patients and clinicians alike. Since integrating with our therapeutic development business, Fulgent is also developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform.

By merging our fields of expertise, we aim to become a fully integrated precision medicine company. Summary of Position The Quality Manager will work closely with the Director of Corporate Quality Assurance to support on-going responsibilities and defined goals by ensuring activities are in compliance to all Fulgent Genetics Management System, and consequently in compliance to the regulating agencies and standards.

The Quality Assurance Manager will be responsible for leading initiatives to ensure process consistency among all Fulgent Genetics sites and ensuring smooth quality transition for new acquisitions. Additionally, the Quality Assurance Manager may be responsible for the leadership, support and oversight of the positions indirect reports. Key Job Elements The Manager must be vigilant to ensure all business locations work in consort and any process change is analyzed for impact to other areas of the regulated business (Operations, Client Services, Pathology, IT) and advise accordingly.

Responsible for direct oversight and development of Quality team personnel while serving as a strategic partner to laboratory operations leadership. Specific activities associated with the support role include (but are not limited to): IT (including LIS and interfaces) compliance activities Laboratory Licensure Compliance Client Communication Review Regulatory Compliance Regulates all Quality Assurance (QA)/Quality Inspection (QI)/Quality Control (QC) to ensure laboratory standards and regulations are maintained.

Determine best-practices and support standardization across all sites (for areas of the regulated business) for the following:
Quality metrics reviews (monthly and quarterly) Standard Operating Procedures Audits (internal and external) Training & Competency Program Referral Lab selection Document control Corrective Action / Preventative Action (CAPA) Safety practices PHI / PI (Confidentiality) Provide direction and management oversight for QMS activities including (but not limited to):
Administer and monitor the Corrective Action / Preventative Action (CAPA) program. Enforce key performance indicators for quality as established by the Laboratory medical Director. Ensure compliance of Proficiency Testing programs. Review & approve Standard Operating Procedures (SOPs) for compliance to the QMS. Assess proper level of training & competency for process changes. Manage elements of document control. Assist in laboratory logistical changes Provides direction and support for new testing and new technologies.

Coaches, mentors, leads and manages employees. Ensures that training and other personal development programs are in place for succession planning and the development of direct reports. Ensures that performance opportunities are proactively managed through the performance management system. Actively participates on cross functional teams (may include facilitation) and shares information, as appropriate, with direct reports. Effectively communicate with stakeholders and/or managers in other departments.

Actively leading in investigation issues and formulating action plans to resolve deviations.

Knowledge/Experience

* Bachelor's degree in chemistry,…