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Molecular Pathology Laboratory Network, Inc. (MPLN) is a privately held, College of American Pathologists, New York State Department of Health and

ISO15189

accredited molecular diagnostic laboratory specializing in oncology, infectious disease testing, women's health testing and a growing clinical trials business. MPLN is seeking a qualified Quality Systems & Compliance Manager to join our dynamic team. General Summary of Position The Quality Systems & Compliance Manager provides oversight and coordination of MPLN's quality management system (QMS) and regulatory compliance activities to ensure adherence to applicable federal and state regulations, accreditation standards, and organizational quality requirements. The position works collaboratively with laboratory leadership, functional managers, and the multidisciplinary Quality Committee to monitor effectiveness, identify compliance risks, and coordinate quality improvement activities in alignment with MPLN's mission and strategic goals. The Quality Systems & Compliance Manager works independently, reports directly to the Laboratory Director, and maintains an indirect reporting relationship with executive management. The role has four primary responsibilities:

Regulatory Compliance :

Monitor applicable regulatory and accreditation requirements, communicate changes that may affect laboratory operations, maintain compliance documentation, identify gaps, and coordinate and verify proper implementation of necessary updates.

QMS Oversight:

Monitor QMS effectiveness, review quality trends, coordinate internal audits and external inspections, oversee quality events and corrective action plans, and verify that required quality activities are completed and appropriately documented.

Compliance Tracking and Gap Assessment:

Maintain regulatory compliance tracking tools to document applicable requirements, corresponding QMS controls, status, and identified gaps. Coordinate follow-up activities to ensure compliance deficiencies are appropriately addressed.

Quality Committee Coordination:

Partner with laboratory leadership and the multidisciplinary Quality Committee to coordinate the implementation of quality initiatives, address compliance gaps, and monitor departmental quality responsibilities across clinical laboratory and clinical-trial activities. Future growth includes supporting the evaluation and implementation of additional quality and regulatory requirements as the organization expands into new services, partnerships, or markets.

ADDITIONAL FUNCTIONS, DUTIES, AND RESPONSIBILITIES

• Maintain QMS documentation, records, and compliance tracking tools to support ongoing monitoring and inspection readiness.
• Serve as a primary point of contact for external parties regarding quality system matters, including regulatory, accreditation, and client-sponsored inspections.
• Manage applications, renewals, and ongoing maintenance of laboratory licenses, certifications, and accreditations to ensure timely submission and continued regulatory compliance.
• Provide guidance and training to laboratory personnel regarding QMS processes, regulatory requirements, and quality responsibilities.
• Prepare and present quality performance reports and compliance updates to laboratory leadership and executive management.
• Collaborate with functional managers and directors to address quality concerns and support interdepartmental continuous improvement initiatives.
• Escalate significant quality and regulatory compliance concerns to the Laboratory Director and executive management, as appropriate.
• Maintain effective working relationships with internal and external stakeholders.
• Maintain confidentiality of patient, client, and laboratory information and comply with all organizational policies and procedures.
• Perform other duties as assigned to support organizational quality objectives and operational needs.

KNOWLEDGE, SKILLS AND EXPERIENCE REQUIRED

• A minimum of five years of experience in a regulated laboratory or related technical environment, including at least two years of experience in quality management, quality systems, or regulatory compliance activities.
• Working knowledge of CAP accreditation standards and CLIA regulatory requirements, including their application within clinical laboratory operations.
• Ability to interpret applicable regulatory and accreditation requirements and translate them into practical laboratory procedures and quality system controls.
• Excellent interpersonal, written and verbal communication and problem-solving skills.
• Strong organizational skills and the ability to coordinate activities across departments.

EDUCATION, LICENSE OR CERTIFICATIONS REQUIRED

• A bachelor's degree in science or a related field.

PREFFERED QUALIFICATIONS

ISO 15189

experience

• Clinical trial/biopharma laboratory experience

ENVIRONMENTAL / WORKING CONDITIONS

• Work in well-lighted and ventilated work areas.
• Slight potential for exposure to infectious materials.
• Slight potential for chemical exposure.
• Possible exposure to communicable diseases, toxic substances and/or hazardous materials.

PHYSICAL / MENTAL DEMANDS

• Ability to stand, walk or sit for extended periods of time.
• Finger dexterity required to manipulate objects.
• Communication skills using the spoken and written word.
• Requires eye/hand coordination.
• Ability to hear within normal range.
• Occasional stress when dealing with patients, clients and multiple demands.

MPLN offers a flexible benefit package that includes a 401k plan, medical, dental, vision, life insurance, short- and long-term disability options as well as vacation time and medical leave. Applicants must be able to pass a pre-employment drug test and background check. MPLN is an

Equal Opportunity Employer Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Vision insurance

Education:

Bachelor's (Required)

Work Location:

In person