Quality Management System Manager

The QMS Manager provides direction and leadership for accreditation of various environmental testing in accordance with ISO 17025 standards, including maintenance of the quality manual, creation, and maintenance of SOPs, adding methods to ISO 17025 scope, and review of all quality indicators produced within the MA SPHL.

The incumbent also provides guidance, consultation, and oversight to Technical and General Supervisors and other laboratory staff to aid in timely, quality testing to ensure the public’s health.

Learn more about what it’s like to work at the Bureau of Infectious Disease and Laboratory Sciences.

• Coordinate with Director of Quality Management Systems to provide direction and leadership for QA activities for all laboratory divisions within the MA State Public Health Laboratory including the Division of Analytical Chemistry, Microbiology, Virology, Sexually Transmitted Infections & Mycobacteriology, and Central Laboratory Support Services; oversight includes but is not limited to personnel qualifications and competency, quality control, pre and post analytic systems, proficiency testing, complaint investigations, quality assessment review, method verification and validation, QA monitors, and staff training.
  
• Assist in implementing and maintaining ISO 17025 Accreditation. Collaborate with MA SPHL ISO accredited laboratories to ensure compliance to A2LA accrediting body. Participate in CLIA, CAP, DEP, ISO: 17025, AOAC, FERN and FDA survey processes, including pre-survey preparation and follow-up of any deficiencies.
• Perform internal audits of each lab section along with the Division Director and/or the lead Technical Supervisor. Manage ISO internal audit schedule. Make recommendations to the Division Director and Lab Director to note any weaknesses found. Co-facilitate QA management reviews.
• Participate in conference calls, attend mandatory out of state conferences. Determine evidence and develop timelines to address non-conformities identified during gap analysis to achieve and maintain accreditation.
• Oversee training of laboratory staff in Quality Assurance policies, procedures, activities, and regulations.
• May include functions in support of emergency declaration.

• Extensive knowledge of quality assurance, including proficiency testing, quality control processes, key performance indicators (KPI), method validation and verification procedures.
• Extensive knowledge of quality management systems and quality improvement techniques and tools.
• Familiarity with laboratory information systems (LIMS) and their QA and regulatory requirements.
• Working knowledge of chemistry, molecular biology, and microbiology laboratory tests and techniques as well as food testing protocols, public health, and epidemiology.
• Thorough knowledge of laboratory equipment and instrumentation, including those used for real-time PCR, and chemical analysis such as thermocyclers, GC-MS, ICP-MS, LC-MS/MS, and Maldi-TOF.
• Knowledge of safely working with toxic substances and infectious agents, including select agents.
• Familiarity of the principles and practices of organizational behavior.
• Knowledge of the principles and practices of management and supervision.
• Strong organizational skills.
• Technical expertise to direct all aspects of a comprehensive quality assurance program for a public health laboratory.
• Ability to read and understand technical materials.
• Ability to work independently with minimal supervision.
• Excellent written and oral communication skills.
• Ability to keep up with the current regulations and develop policies and procedures to comply with any changes.
• Ability to select and develop staff by utilizing participatory management, personnel assessment, and performance review.

Special Requirements:

As part of the pre-hire process, you will be required to submit transcript(s) for review for the Clinical Laboratory Improvement Amendments (CLIA) verification process. If selected as the preferred candidate, you will be required to submit an official transcript from each accredited academic institution to verify the above. Please note that we will be unable to move forward with your application for this position if you do not meet CLIA qualifications.

The DPH Bureau of Infectious Disease and Laboratory Sciences (BIDLS), predominantly located in Jamaica Plain, provides public health response to infectious disease. These services include programmatic and epidemiologic response, as well as laboratory testing through the State Public Health Laboratory (SPHL).

Infectious disease response services address concerns of the general public as well as those disproportionately affected by infectious disease through a variety of risk factors. BIDLS administers ongoing disease reporting for over 90 reportable diseases in the state. Disease reporting review and follow-up with clinical providers and local boards of health is a central function of the bureau. Surveillance activity is complemented by an extensive contracted service system. These services are funded through state and federal resources and include prevention education, community outreach screening for infectious disease, immunization services, health service navigation, medical case management, insurance enrollment, housing assistance, and referral and linkage to infectious disease treatment.

The SPHL provides scientific expertise and capacity to identify infectious agents, chemical agents, and other toxins that cause human disease. The SPHL is an active partner in joint activities with other bureaus/agencies such as environmental health, food and drug, agriculture, disease prevention and health promotion programs, and public safety. The SPHL is a reference laboratory of the national Laboratory Response Network (LRN) and is a U.S. Centers for Disease Control and Prevention (CDC) Select Agent laboratory. SPHL staff work closely with laboratory and disease prevention programs at the CDC, and partners with the U.S. Department of Homeland Security (DHS).

The mission of the Massachusetts Department of Public Health (DPH) is to prevent illness, injury, and premature death, to assure access to high quality public health and health care services, and to promote wellness and health equity for all people in the Commonwealth. We envision a Commonwealth in which all people enjoy optimal health. Massachusetts ranks among the healthiest of states according to comparative analyses, but we face numerous challenges, including chronic and infectious disease, substance abuse, violence, preventable hospitalizations, and health disparities.

DPH coordinates programs and policies to address specific diseases and conditions and offer services to address the needs of vulnerable populations. We also develop, implement, promote, and enforce regulations and policies to assure that the conditions under which people live are most conducive to health and enable people to make healthy choices for themselves and their families. We license health professionals, healthcare facilities and a variety of businesses that impact public health. We operate the state laboratory and four public health hospitals. We monitor health status and manage vital records including births, marriages and deaths. We educate people about public health issues and work closely with local boards of health and community partners to identify and solve public health problems.

More information can be found at: Department of Public Health | Mass.gov

A tax & background check will be completed on the recommended candidate as required by the regulations set forth by the Human Resources Division prior to the candidate being hired.

Education, licensure, and certifications will be verified in accordance with the Human Resources Division’s Hiring Guidelines.

Education and license/certification information provided by the selected candidate(s) is subject to the Massachusetts Public Records Law and may be published on the Commonwealth’s website.

If you require assistance with the application/interview process and would like to request an ADA accommodation, please click on the link and complete the ADA Reasonable Accommodation Request Form

For questions regarding this requisition, please contact the Executive Office of Health and Human Services Human Resources at 1-800- 510-4122 Ext. 4.

Comprehensive Benefits

When you embark on a career with the Commonwealth, you are offered an outstanding suite of employee benefits that add to the overall value of your compensation package. We take pride in providing a work experience that supports you, your loved ones, and your future.

Want the specifics? Explore our Employee Benefits and Rewards!

COVID Vaccine: As a condition of employment, depending on job assignment and location, employees may be required to have received COVID-19 vaccination and/or other vaccinations, or to have been approved for a vaccination exemption prior to their start date. Details relating to demonstrating compliance with this requirement will be provided to applicants selected for employment.