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Director Quality Systems & Regulatory Affairs

Southaven, Mississippi

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Job ID 21000PD4

Available Openings 1


Fresenius Medical Care is a people business. Our success depends on having the best and brightest employees and helping them attain their personal and professional goals while delivering excellence in patient care and business results. Our employees embody our culture which is based on six core values: patients and partners first, honesty and integrity, quality and compliance, collaboration, no-limits mindset and results oriented. These values support our promise to improve the quality of life of every patient every day.


Supports FMCNA’s mission, vision, core values and customer service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and division/company policy requirements. Directs, leads, establishes, implements, and maintains all Quality Management Systems (QMS) policies, programs, and activities that ensures conformance to all regulatory and ISO 15189 standards. Provides technical and organizational leadership and guidance to Quality/Quality Systems, Regulatory Affairs activities, Safety activities and business initiatives.


  • Provide strategic leadership of short- and long-term goals using thoughtful techniques in the communication of the company’s mission and core values as a means to implement positive change and/or create organizational structure within the assigned business unit(s).

  • Lead operational efforts through subordinates to complete the administration of business processes and services to ensure the operations effective achievement of goals within the assigned business unit(s).

  • Responsible for the strategic vision, administration, and direction of the QSRA area.

  • Directs appropriate response to subpoenas/summons process, release of records/information, HIPPA privacy program and legal and regulatory news watch.

  • Directs and has overall responsibilities for all aspects of the QSRA programs, policies, and activities using sound understanding of technical and scientific principles and all regulatory and ISO 15189 standards adopted by Spectra Laboratories, Inc.

  • Has overall responsibility for receiving and managing inspections and surveyors and required activities necessary to bring the organization to compliance resulting from deficiency findings.

  • Regularly reviews quality system standard operating processes and procedures and making changes as necessary to ensure compliance and efficiency of the QMS and the QSRA area.

  • Maintains compliance with all regulations for CLIA, the states of CA, NY, PA, MD, RI, FL (as well as other states as deemed necessary), and requirements under A2LA (ISO 15189).

  • Provides guidance and quality planning activities for validation studies. Works with laboratory staff to evaluate new processes/procedures for conformance with Spectra and government requirements.

  • Manages non-conforming events investigation and resolution.

  • Direct and control the broad activities of the business unit(s) through the interpretation, application and implementation of company-wide policies and processes appropriate to the functional area(s).

  • Ensure that budgets and schedules are within company requirements with significant organizational responsibility for the overall control of planning, staffing, budgeting, expense priority management, and recommendation and implementation changes of current methods.

  • Provide leadership, guidance and coaching for all direct reports to maintain an engaged and productive workforce; partnering with Human Resources on employee matters.

  • Collaborate with employees in the establishment of clear and concise development plans to ensure succession planning and the advancement of future leaders within the organization.

  • Collaborates with Directors, Managers and Supervisors of all internal business functional units in monitoring and auditing activities; ensures appropriate corrective actions are taken to align with the business mission, goals and objectives.

  • Guides, coordinates and leads the Quality Council Management Review meetings and associated functions to maintain conformance with ISO 15189.

  • Directs the development, implementation and monitoring of business functional unit quality indicators.

  • Develops and manages processes that ensures detection of nonconformance and utilization of root cause analysis tools.

  • Monitors proposed and upcoming legislative and regulatory activities, both locally and nationally, regarding the clinical laboratory, workplace health and safety, and other pertinent business issues.

  • Directs the laboratory compliance to CLIA, ISO 15189, CAP and New York proficiency testing requirements and OSHA health and safety regulations.

  • Directs the Safety Program to assure compliance with all state, county, city, Fire and Safety Codes, OSHA, Fresenius policies and practices, and other regulatory agencies’ requirements.

  • Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.


  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Travel may be required to coordinate consistent practices between Spectra lab sites and attend education and development.


  • Will be responsible for the direct and indirect supervision of various levels of QSRA staff.
  • Bachelor’s Degree in Clinical Science required; Advanced Degree preferred


  • Licensed California Clinical Laboratory Scientist (CLS) and meets criteria for NY State CLS
  • 10+ years’ related experience.
  • 5+ years’ experience as a Manager; or 5+ years’ experience in a senior managerial role.
  • Strong management skills with the ability to lead cohesive and productive teams.
  • Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact.
  • Excellent oral and written communication skills.Proficient knowledge of laboratory regulations and compliance methods
  • Previous regulatory experience specifically in the areas of quality management and statistical analysis tools, ISO 15189, JC, CLIA, NY, and OSHA required.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

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