Sr. Manager, QA
This position is responsible for the planning, development, organization, management, implementation, and outcome monitoring of Corporate Quality Assessment-CP programs for Quest Diagnostics Hospital Laboratories. These programs must support compliance with regulatory and company requirements and drive the improvement and/or sustainability of medical quality while driving QHLs to get and stay inspection ready, and
ultimately engage in continuous, sustained, quality improvement.
- Scope of responsibilities: Quest Diagnostics Hospital Laboratories, to include: hospital managed laboratories, laboratory managed partnerships and joint venture sites as applicable, This includes all areas of clinical testing as well as ancillary/support functions, including specimen collection, specimen processing, referral testing, materials management, and client services.
- Maintain strong knowledge of and ensure compliance with regulatory requirements, to include accrediting bodies, federal, state, and local requirements as well as Quest Diagnostics policies. Direct the development and deployment of the internal inspection program for Quest Diagnostics testing facilities. Ensure consistency of inspection findings, timely reporting, and submission of credible corrective actions.
- Establish and maintain relationships with Quest Physician Lab Services
- Direct the development and deployment of programs to provide technical and consultative support to Quest Diagnostic Regional Laboratory Quality Assessment Departments as it applies to the hospital environment.
- Develop and deploy standard quality policies and programs across the system.
- Develop, monitor and evaluate quality management reports and metrics as required. (CAP and RQI,)
- Support the management of enterprise wide medical quality management projects and quality system initiatives for clinical pathology as required. (EQP)
- Develop and mentor Corporate Quality Assessment Managers as applicable.
- Communicate Corporate Quality Assessment Program effectiveness to the Director of Corporate Quality Assessment, to include objective criteria to assess laboratory quality.
- Ensure enrollment and effectiveness of Proficiency Testing programs.
- Facilitate problem resolution related to quality issues identified within Quest Diagnostics manager hospitals
- Support or manage agency complaint investigation in collaboration with Medical Regulatory Affairs
- Communicate/interact with regulatory agencies as pertinent.
- Prepare written communications and deliver presentations as required.
- Assist in special projects and activities as required.
- Bachelor's degree (chemical, physical, biological or clinical laboratory science or medical technology)
- Certification by American Society for Clinical Pathology (ASCP or equivalent)
- Knowledge of Quality Assurance and statistical Quality Control programs
- Strong working knowledge of regulations and accreditation standards related to the clinical laboratory industry
- 10 or more years of clinical laboratory experience, with 3 or more years in a managerial role
- Previous experience as an inspector
- Previous experience interacting with high-level staff within an organization
- Possesses excellent communication (verbal and written), influencing, and collaboration skills
- Ability to work independently and effectively plan/organize work and projects
- Demonstrated team building and problem solving skills
- Competent with MS Office
- American Society for Quality (ASQ) certification as Quality Auditor
- QMS certification or must obtain
- Clear understanding of the Quest Diagnostics organization, structures, and strategies and the impact of introducing major program initiatives
- Advance Degree preferred
- ASQ Certification in Quality Management (Manager of Quality/Organizational Excellence) preferred