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Associate Quality Director-remote

Company: Labcorp
Location: Burlington
Posted on: September 13, 2021

Job Description:

SUMMARY

Responsible for developing and implementing quality policies/procedures to ensure clinical trial services for Labcorp laboratories comply with government regulatory requirements. Provides leadership, strategic direction and interpretation of regulatory requirements for Labcorp Diagnostic laboratories relative to clinical trials testing and NY State Submissions.

 

RESPONSIBILITIES

Monitors the environment for regulatory compliance intelligence in the company's areas of interest to ensure that current awareness is maintained across the organization and, where necessary, that company procedures are introduced or adapted to respond to changes in the regulatory environment;

 

  1. Maintain systems and tools in support of Regulatory Intelligence activities;
  2. Ensuring that appropriate regulatory compliance information is maintained and made available across the company;
  3. Develop targeted summary documents, internal guidance, training materials and communications to ensure leadership and staff are informed on regulatory compliance information, and how existing procedures might need to be amended to remain in compliance;
  4. Provide appropriate regulatory compliance information, advice, support and training to laboratories;
  5. Support client-facing staff by proactively providing advice on regulatory compliance issues;
  6. Support regulatory authority inspections at laboratories as appropriate;
  7. Perform other duties, as assigned by management
  8. Assures compliance to other applicable regulation (e.g. CAP/CLIA, NY State, GXP, and ICH guidelines).
  9. Audit laboratories to ensure quality management systems are in compliance with 21 CFR 820, 812, 50, 56 and ISO 14971
  10. Act as an advisor to management on complex quality related matters
  11. Manage corporate NY State submissions
  12. Promote a culture of Quality 
 

MINIMUM QUALIFICATIONS:

 

Required:

  • 8 years in regulatory environment (experience in GXP roles)
  • Ability to support new company initiatives to help achieve company goals. Initiatives may involve multiple functions over multiple time zones, providing the opportunity to demonstrate in depth knowledge and further establish skills in complex task management and communication
  • Ability to analyze, interpret, and summarize regulatory information and develop summary documents
  • Proven interpersonal sensitivity to lead groups belonging to different fields/cultures, etc.
  • Coordinates communication from the team across multiple levels of the organization (leadership through individual contributors and external stakeholders)
  • Strong professional knowledge of quality management systems to include the FDA quality system regulations
  • GxP knowledge and experience applying GxP requirements to the conduct of drug development.
  • B.S. degree in Biology, Chemistry or related field

 

*This job description reflects the essential functions of the position and excludes those that may be incidental to the performance of the job. In no way is it stated or implied that the principle functions are the only duties to be performed. Employees will be required to follow any other job-related instructions and to perform any other job related duties requested by their supervisor.

Keywords: Labcorp, Burlington , Associate Quality Director-remote, Other , Burlington, North Carolina

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