QA Manager

  • Company: AmerisourceBergen
  • Location: New Hyde Park, New York
  • Posted: November 30, 2016
  • Reference ID: 00001GJF

Under general direction of Country Manager, plays a pivotal role to the implementation quality assurance/compliance directives. Responsible for ensuring compliance of the country to World Courier's Quality and Compliance program . Provides guidance to offices and colleagues on all matters pertaining to quality and compliance. Ensure country's compliance to local regulatory requirements as it pertains to quality.


  1. Convert Directives into local Working Instructions, SOPs, etc., as applicable
  2. Assist in purchasing, qualification and set up of technical equipment according to Group, Regional and Local requirements
  3. Steer local interpretation of regulatory and World Courier internal requirements
  4. Assessment of quality related activities/ non-conformances on local level
  5. Provide response to client questionnaires in close cooperation with branch/ country manager and Regional Quality Representative
  6. Schedule client audits and coordinate the audit agenda in close cooperation with branch/ country manager and Regional Quality Representative
  7. Manage the preparation of CDAs on local level
  8. Manage on site preparation for client audits in close cooperation with branch/ country manager and Regional Quality Representative
  9. Accompany audits as applicable
  10. Coordinate the preparation of audit response in close cooperation with branch/ country manager and Regional Quality Coordinator
  11. Follow up on pending audit observations
  12. Coordinate local CAPA and Change Management activities
  13. Sign off local CAPA and Change Management documents
  14. Follow up on pending activities
  15. Archiving of finalized local CAPA and Change Management documents
  16. Enter all relevant data into QA SharePoint to allow for timely quality metric generation
  17. Authorizing local SOPs
  18. Archiving of master copies of local SOPs (electronic master and in case of hard-copies signed original)
  19. Establish appropriate training material and conduct training for general Quality topics, e.g. QA SOP, current laws, regulations, directives, etc.
  20. Act as co-auditor during internal audits performed by Regional Quality Manager, or act as lead-auditor under guidance from Regional Quality Manager (satellite offices only)
  21. Oversee self-inspection, check reports, escalate non-conformances to Local Management and Regional Quality Manager
  22. Assist in inquiries resulting from new requirements from authorities and/ or clients
  23. Coordinate the ISO 9001 and ISO 14001 audit programs in the Country
  24. Steer Local Management Review meetings
  25. Manage subcontractor qualification in close cooperation with branch/ country manager and Regional Quality Manager
  26. Steer the generation and review of local Technical/ Quality Agreements with clients and subcontractors; assist in the review of regional/ global Technical/ Quality Agreements
  27. Assist in setting up Risk Management processes
  28. Performs related duties as assigned.

  1. Diploma/Bachelor's Degree Program or equivalent combination of experience and education.
  2. Normally requires a minimum of one (1) year experience in operations or customer service departments within World Courier

  1. Ability to collaborate and interact effectively with colleagues
  2. Excellent interpersonal skills
  3. Broad operational background in World Courier processes
  4. Basic understanding of Quality Management processes (e.g. ISO 9001)
  5. Adequate GxP expertise (World Courier GxP policy)
  6. 1 to 2 years working experience in Quality environment
  7. Fluency in local language and adequate English skills

The work environment characteristics described here are representative of those an associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Share this Job