As a senior member of the quality assurance team, you will work collaboratively with laboratory personnel and groups throughout the organization to ensure compliance with regulatory requirements and to support a diverse array of projects and initiatives. This position contributes to QA activities across multiple quality system requirements, such as CLIA/CAP, GCP, ISO and FDA regulated environments.

You will lead, support and coordinate efforts that foster quality and ensure that all pre-analytical, analytical and post-analytical processes are consistent with our company values and mission. 

This is an Onsite position

Internal Grade : 49 

1) Leadership  

• Direct, advocate for and enable visibility of quality processes.  
• Ensure accountability within all areas of the lab (pre-analytical, analytical and post-analytical) so that every employee consistently exhibits behavior that promotes and supports quality. This can be done by working with lab liaisons such as lab supervisor or other designated members.
• Oversee and co-ordinate a QA specialist team to perform quality-related activities and maintain associated documentation
• Develop, implement, and maintain CLIA, GCP quality systems, policies, and SOPs.
• Acts as a liaison with external entities, such as customers, auditors, and/or regulatory agencies or matters relating to the Quality Management System.
• Support the tracking, monitoring, and presentation of Management Review, including developing both operational and quality metrics.
• Support the internal audit program and external audits perform by regulatory/inspection agencies, BioPharma/Clinical Operation Partners, as required.
• Maintain current and accurate records of all relevant communications, audits, corrective action, plans, and CAPA effectiveness, monitoring, as required.
• Maintain supplier contracts and conduct supplier assessments for critical product manufacturers, as needed.
• Manages the documents/record management process and associated training programs.
• Initiates or supports as needed quality improvement initiatives to improve performance and/or mitigate quality or compliance risks.

2) Licensing and Accreditation 

• Direct internal inspection process of the lab to ensure compliance with applicable federal, state, and local regulations, and Quest Diagnostics standards.  
• Review and ensure that corrective action is implemented when non-conformances are found. 
• Monitor published guidelines for revisions to regulations and/or accreditation standards and ensure laboratory compliance. Serve as a resource regarding Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) regulations accreditation standards for all sites. 
• Communicate changes in the laboratory (such as CLIA lab director and addition or discontinuation of tests) to local and national regulatory agencies in a timely manner
• Ensure all testing facilities/personnel have appropriate licensure and accreditation as deemed by federal, state, and local regulations.  
• Proficiency Testing: Identify all tests performed and ensure enrollment and participation in external proficiency testing or alternative proficiency testing for each test. Ensure that all proficiency testing is reviewed, and corrective action is complete for all non-conformances.  
• Ensure that a defined instrument to instrument, method to method, and laboratory to laboratory comparison process, with fixed criteria for accessing acceptability, is performed and documented at least semi-annually.  

3) Quality Assurance/Quality Improvement  

• Conduct monthly QA meetings with required participation by QA and laboratory representatives having an impact on pre-analytical, analytical and post-analytical phases of testing (except Billing).  
• Create effective materials (e. g., graphs, charts) to promote Quality Improvement (QI) and present plans and results at monthly meetings.  
• Develop, monitor and improve Quality Assurance specific quality indicators, including but not limited to: Reportable Quality Issues, Proficiency Testing outcomes, Revised Reports tracking, and performance on inspections.  
• Ensure all applicable employees are trained and comply with policies.  
• Ensure all QA policies have annual review.  
• Ensure a process is in place to resolve customer complaints regarding pre-analytical, analytical, and post- analytical issues.  
• Ensure all duties are appropriately delegated as required by applicable federal, state and local regulations.  

Required Work Experience: 

• A minimum of one year of supervisory experience is required.

Preferred Work Experience:  

• A minimum of 5+ years relevant experience in the medical device, clinical laboratory, pharmaceutical, biotechnology, or diagnostic industries with 3+ years in management role.
  
• Experience with managing GCP/GMP activities across multiple quality system requirements (e.g. operating under FDA, ISO, CLIA and CAP)
• Experience or familiarity with High complexity Clinical Laboratory operations, Medical Devices and Invitro Diagnostics, Companion Diagnostics or, with a working knowledge of relevant federal/ international regulations and standards. Experience in genomic testing and next-generation sequencing will be a plus.
• Process-oriented, with the ability to demonstrate good judgment and decision-making.
• Ability to identify quality issues and effectively interface with internal and external teams.
• Experience managing external audits in associated with FDA, ISO, CLIA & CAP inspections. MDSAP or OUS-related inspection experience is a plus.
• Technical knowledge of MDR/IVDR, with experience transitioning from MDD/IVDD

Physical and Mental Requirements:  

• Ability to sit and/or stand for long periods of time.

Skills:  

• Ability to communicate clearly and concisely with all stakeholders
• Strong attention to detail and the ability to manage multiple priorities with aggressive timelines
• Ability to manage multiple projects and work independently
• Strong written and communication skills
• Understanding of HIPAA and importance of privacy of patient data
• Must be able to travel as needed to conduct QA audits
• Ability to work in a fast-paced setting and adjust to a changing environment.

People Leader Responsibility:

• Knowledge of management, administrative and supervisory practices, with ability to plan and supervise QA staff.

EDUCATION

• Bachelor's degree in a scientific discipline or a related field required
• Master's degree in a scientific discipline or a related field preferred

LICENSECERTIFICATIONS

Certifications Qualification as General Laboratory Supervisor as defined by CLIA '88

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.