Quality Manager

FULGENT THERAPEUTICS LLC•Alpharetta, GA

18d•Onsite

About The Position

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. 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.

Requirements

Bachelor’s degree in chemistry, biology, or related discipline.
5 years demonstrated experience in a Clinical/Anatomic Pathology Laboratory setting.
Experience with Quality Management/Improvement, including performing audits and demonstrated record enforcing regulatory standards.
Demonstrated leadership and management responsibilities within a regulated environment.
Visual acuity and analytical skill to distinguish fine detail.
Serve as a subject matter expert for CAP, CLIA, state regulatory agencies, and accreditation readiness activities.
Superior ability to self-manage and prioritize workload.
Experience with the elements of document control.
Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.
Ability to multi-task and work in a fast-paced, high-stress, deadline driven environment.
Drive for Results (Service, Quality, and Continuous Improvement) – Ensure procedures and processes are in place that lead to delivery of quality results and continually reassess their effectiveness to achieve continuous improvement.
Communication – Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results.
Teamwork – Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team.
Customer Service Focus – Demonstrate a focus on listening to and understanding client/customer needs and then delighting the client/customer by exceeding service and quality expectations.
Must have understanding of validation, calibration, preventive maintenance, electronic records, among others.
Skilled at root cause analysis and problem solving with a results orientation.

Nice To Haves

Certification as a Clinical/Medical Laboratory Scientist or sub specialty (e.g. ASCP certified Med Tech).
Quality related certification(s) such as ASQ Quality Auditor, Quality Engineer, etc.
Experience or certification with Lean/Six Sigma, TQM, SPC.

Responsibilities

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.
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.