Quality Assurance Manager, Training, and Compliance

TITLE AND CLASSIFICATION:  Quality Assurance Manager, Training, and Compliance/ Exempt

REPORTING LOCATION: Rockville, MD 

REPORTS TO: Vice President, Scientific Operations

PRIMARY OBJECTIVES: Ensure that facility and operational needs are met for the laboratory, business development, and management groups.

DUTIES AND RESPONSIBILITIES:

  • Quality Assurance and Process Improvement
    • Develop and enhance Quality Management System and Quality strategy
    • Identify, monitor, document, and report KPIs
    • Provide Quality training and ensure personnel understand and adhere to Quality requirements, regulations, company SOPs and industry standards
    • Manage internal and external auditing program including planning, conduct, and reporting of audits
    • Host client audit visits, respond to client audit observations, and follow up with clients on CAPAs
    • Oversee document and SOP management
    • Identify and lead process improvement initiatives
    • Manage Quality Assurance vendors as needed
  • Training
    • Manage training program, designated trainers, and associated training documentation
    • Coordinate development and implementation of training modules and sessions
    • Perform annual and refresher training sessions
    • Facilitate onboarding of new employees
  • Regulatory Compliance and Accreditation
    • CLIA, Joint Commission, CA DPH, MD DHMH, NY DOH, CAP, GCLP
      • Oversee compliance with Clinical Laboratory regulations
      • Serve as point of contact, responsible for managing, scheduling, and documenting activities, site audits, and reports.

KNOWLEDGE, SKILLS AND ABILITIES

  • Knowledge and understanding of contract research organizations and GCLP and CLIA regulations.
  • Competence in OECD-GLP requirements preferred
  • Demonstrated ability to work effectively and productively in a team-oriented environment.
  • Creative and flexible problem solver with sound judgment, integrity, and confidentiality.
  • Possess superior planning, organizational, computer, written and verbal communication skills.
  • Ability to effectively network, negotiate, and influence.
  • Demonstrated accountability and responsibility for own work.

EDUCATION AND EXPERIENCE

  • BS/BA degree. MS degree preferred.
  • Certification through SQA, or similar institution preferred.
  • Demonstrated comprehensive knowledge of and experience in quality assurance, quality control, and process improvement.
  • Experience in regulatory and compliance aspects of clinical laboratory and GCLP.

PHYSICAL DEMANDS AND WORK ENVIRONMENT

  • Must be able to sit and use hands to finger, handle and feel.
  • Must be able to lift and move packages weighing up to 50 pounds.
  • Must be able to sit for long periods of time using a computer in a typical office environment in a multi-level facility.
  • Some activities require repetitive motion and reaching, pulling or pushing.
  • In carrying out the duties of the job there may be exposure to fumes, chemical hazards, or exposure to blood, body fluid and tissue.

This job description may be changed to include new responsibilities and tasks or change existing ones as management deems necessary.