OVERVIEW:

The Project Manager of Quality Assurance & Process Improvement is responsible for measuring, monitoring, and reporting quality metrics across clinical and research laboratories. The Manager of QA-PI works closely with the Lab Director and Supervisors to ensure the labs operate efficiently and in compliance with multiple overseeing bodies. This person is responsible for issue spotting and identifying solutions before problems arise. It requires excellent project management skills, data analysis and presentation, and the ability communicate clearly with multiple stakeholders across the organization.

KNOWLEDGE, SKILLS AND ABILITIES:

• Proficiency in project management software (e.g., MS Project, Smartsheet, Trello, or similar)
• Knowledge of laboratory compliance and regulatory standards
• Ability to manage multiple projects simultaneously and prioritize tasks
• Superior verbal and written communication and interpersonal skills.
• Excellent time management skills with proven ability to meet deadlines
• Superior communication and diplomacy skills.
• Extremely proficient in Microsoft Office Suite or related software.
• Excellent organizational skills and attention to detail.
• Excellent analytical, decision-making, and problem-solving skills.

EDUCATION & CERTIFICATION:

• Education – Bachelor’s Degree in Business, Biological Sciences, Finance, or other similar focus
• Lean, Six-Sigma, PMP professional or other certification in project management or process improvement preferred

EXPERIENCE:

• 4+ years of experience in a clinical or research laboratory setting
• 2+ years of project management experience, preferably in a healthcare or laboratory environment
• Experience with LIMS, laboratory automation, or assay development projects is highly desirable
• Preferred prior experience in a clinical laboratory setting. Experience with a variety of laboratory quality management systems, e.g., CAP, ASHI, CLIA, FDA and NYS-DOH CLEP.

PHYSICAL REQUIREMENTS:

• Must be able to traverse the lab facility.
• Must be able to lift up to 15 pounds at a time.
• Prolonged period sitting at a desk and working on a computer

QUALITY ASSURANCE AND COMPLIANCE RESPONSIBILITIES:

• Assist in the maintenance of College of American Pathologists (CAP), American Society for Histocompatibility and Immunogenetics (ASHI) and New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) accreditations.
• Establish QC/QA documentation procedures and monitor QA/QC performance on a variety of systems by gathering relevant data from electronic and hard-copy sources.
• Assure a timely and regular calendar for lab staff to conduct proper qualification, maintenance and calibration of lab equipment and on-line test instruments.
• Perform internal quality audits, recommend changes, and initiate corrective or preventative actions when appropriate.
• Identify relevant quality-related training needs and coordinate training for personnel.
• Coordinate with regulatory and compliance teams to ensure projects adhere to relevant standards (e.g., CLIA, CAP, 21 FCR Part 11, ISO 15189).

PROJECT MANAGEMENT RESPONSIBILITIES:

• Manages multiple related projects (e.g., LIMS & QMS implementation, lab expansions, process improvement).
• Define project goals, timelines, and resources in collaboration with stakeholders.
• Develop detailed project plans and track project performance using appropriate tools.
• Serve as the main point of contact for project stakeholders and ensure clear communication throughout the project lifecycle.
• Identify and resolve project issues, bottlenecks, and risks proactively.
• Support change management efforts and training associated with new systems or processes.
• Prepare and present status reports, updates, and post-project reviews to leadership.

PROCESS IMPROVEMENT RESPONSIBILITIES:

• Establishes quantitative and qualitative metrics, guidelines, and standards by which the company’s efficiency and effectiveness can be evaluated; identifies opportunities for improvement.
• Reviews, analyzes, and evaluates lab procedures in collaboration with lab managers and QA team, creates reports and dashboards to communicate findings
• Implements policies and procedures that will improve day-to-day operations.
• Communicates and explains new directives, policies, or procedures to managers; for major changes, meets with entire operations staff to explain changes, answer questions, and maintain morale.
• Improves customer service and satisfaction through policy and procedural changes.
• Leads coordination and integration of efforts among operations, technology, and customer service divisions to produce smoother workflow and more cost-effective business processes.
• Performs other related duties as assigned.