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 willwork 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, 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.

Preferred:

• 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.

Other

• Willingness to work overtime is required.
• Travel Required: Occasionally
• Weekends/Evenings/Holidays: Yes
  • At times may be required to work weekends/Holidays. Requires flexibility of hours and when a problem arises, may be required to work overtime.

Supervisory Responsibilities

• Yes

Reports To

• Director, Corporate Quality Assurance

Environment

Fulgent Therapeutics LLC is an Equal Employment Opportunity Employer.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. The term "qualified individual with a disability" means an individual with a disability who, with or without reasonable accommodation, can perform the essential functions of the position.

This job description reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

Please note that Fulgent (and its affiliated companies, including Inform Diagnostics and CSI Laboratories) does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Search firms or agencies without an applicable contract and/or express approval to recruit for the role in question - that choose to submit a resume or client information to our career page or to any employee of Fulgent - will not be eligible for payment of any fee(s), and any associated shared data will become the property of Fulgent