Quality Director - Genetics
Primary Location San Jose, California
Worker Location Onsite
Job Number 1272022 Date posted 04/12/2024
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Description:
Job Summary:
Leads quality assurance for both molecular genetics lab and cytogenetics lab. Assists the managing director in clinical and technical operation. Directs and manages the day-to-day quality operations of their specific area of responsibility which includes all personnel activities, technical oversight, general workflow and budget. Ensures compliance with applicable regulatory bodies including of federal, state, professional organization, and local requirements.
Essential Responsibilities:
- Oversees quality assurance and regulatory compliance across the laboratory. Collaborates with laboratory operations leadership and coaches section managers and Sr. Technologists regarding QA and QC.
- Assists the managing director in clinical and technical operation. Collaborates with regional lab QA leadership for projects and integration.
- Directs and manages the day-to-day quality operations for a major clinical laboratory department or multiple sections.
- Recruits, hires, trains, and ensures competency of QA team staff. Motivates and encourages professional growth.
- Participates in the design and evolution of Regional Laboratory and Northern California Region integrated laboratory quality system.
- Performs risk assessment and implements effective risk control process.
- Researches/resolves client quality related problems/issues. Assists with Root Cause Analysis in operational areas.
- Oversees and coordinates quality requirements for assay validation, technical transferring, clinical lab implementation.
- Participates in department, inter-department, inter-facility and inter-regional projects which help the Regional Laboratory achieve its goal of providing quality service and client support in a cost effective manner.
- Oversees deviation management processes.
- Serves as primary quality liaison to TPMG IT, LIS Support systems and KPIT for ongoing and new issues.
- Performa quality gap analyses as appropriate.
- Coordinates quality assurance for the integration of laboratory information systems.
- Hosts licensing and accreditation assessments; compiles and manages responses to any agency deficiencies identified.
- Interacts with TPMG Regional Quality and Compliance.
- Performs or coordinates interim self-assessment processes and activities.
Basic Qualifications:
Experience
- Minimum five (5) years of experience in a high-volume clinical laboratory required.
- Minimum three (3) years of experience in a supervisory/managerial position required.
Education
- Bachelors degree in clinical scientific, laboratory, or related field required.
License, Certification, Registration
- Limited Specialty License (California) OR Clinical Laboratory Scientist License (California)
Additional Requirements:
- Knowledge of federal, state, local, and accreditation and licensing agency regulations.
- Practical experience in CLIA/CAP application, inspection, and quality management.
- Must be able to work in a Labor/Management Partnership environment.
Preferred Qualifications:
- Certification in quality auditing or quality engineering preferred.
- Masters degree in clinical scientific, laboratory, or related field preferred.
Primary Location: California,San Jose,NCAL Regional Genetics Laboratory
Scheduled Weekly Hours: 40
Shift: Day
Workdays: Mon, Tue, Wed, Thu, Fri
Working Hours Start: 08:00 AM
Working Hours End: 04:30 PM
Job Schedule: Full-time
Job Type: Standard
Worker Location: Onsite
Employee Status: Regular
Employee Group/Union Affiliation: NUE-NCAL-09|NUE|Non Union Employee
Job Level: Manager with Direct Reports
Department: Regional Genetics Lab - Med Adm Fac Strat Activity - K - 0206
Pay Range: $176900 - $228910 / year
The ranges posted above reflect the location in the job posting. The salary range may vary if you reside in a different location or state than the location posted.
Travel: Yes, 10 % of the Time
On-site: Work location is on-site (KP designated office, medical office building or hospital).
Worker location must align with Kaiser Permanente's Authorized States policy.
At Kaiser Permanente, equity, inclusion and diversity are inextricably linked to our mission, and we aim to make it a part of everything we do. We know that having a diverse and inclusive workforce makes Kaiser Permanente a better place to receive health care, a more supportive partner in our communities we serve, and a more fulfilling place to work. Working at Kaiser Permanente means that you agree to and abide by our commitment to equity and our expectation that we all work together to create an inclusive work environment focused on a sense of belonging and wellbeing.
Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status. Submit Interest
Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status. Submit Interest
