Director, Quality Management Systems, APAC

Summary of Role:  

  • Direct and Implement the Quality Management System of the Asia Pacific Management Team.
  • Direct all AP quality sub-systems, e.g. NC/CAPA, Complaints, Doc. Management, Management Reviews, Change Control, etc.
  •  As part of the QS AP Team, drive the business forward by fostering a culture of compliance, respect, accountability and achievement with all AP plants, and enabling other stakeholder functions.


Responsibilities in Detail:

  • Responsible for directing the AP Quality Management System and its certification status according to ISO 13485, CFDA and other local requirements coming from the different regulations of markets or countries.
  • Implement and maintain EQMS Tools for QMS such as TrackWise, Windchill, Synertrade, etc.  Ensure compliance & effective life-cycle management of these tools.
  • Evaluation, assessment and report to AP management quality organization about the effectiveness of the AP Quality Management System and sub-systems.
  • Support AP plants to maintain fully compliant Quality Management Systems that fulfill their AP/GQMS, local and target markets requirements
  • Manage Audit System and co-ordinate with Director, AP QS Ops all internal and external audits.
  • Maintain the AP Customer Complaints System and report regularly to AP management.  Ensure customer complaints are resolved effectively through the EQMS system.
  • Maintain the AP CAPA system; follow up of the implementation and assessment of the effectiveness of corrective actions/corrective actions.
  • Maintain the AP Document Management System; manage the implementation and assessment of the effectiveness of Document Control.  Responsible for Change Control.
  • Handle additional assignments with appropriate instructions from the supervising manager.
  • Interface with regulatory agencies regarding QS requirements.   Manage regulatory inspections from TGA, CFDA, NB., Japan, KFDA, etc.
  • Organize regular AP QMS Management Review Meetings.


Job Environment:

The position requires at least 60% travel within the Asia Pacific region. The work environment is multicultural & multilingual in a highly matrixed organization.


Career Path:

The role has direct management responsibility. Long term opportunities include promotion to senior level management positions.


Qualifications, Experience and Characteristics Required:

  • Completed minimum BS university-level education with a minimum professional experience of more than 8 years.
  • Advanced knowledge of applicable quality management standards (e.g. GMP, CFDA, US-FDA, and MD EU, ISO 9001 and ISO 13485) and medical & medicinal devices regulations.
  • Demonstrated ability to develop relationships and communication with colleagues, subordinates, superiors and internal and external customers. Demonstrated ability to be an effective team player.
  • Demonstrated high accountability for achieving targets and objectives as required of the position. Demonstrated proactive and solution oriented approach towards problems
  • Demonstrated handling of meeting facilitation, moderation, and presentation techniques both. written and oral
  • Demonstrated ability to prioritize multiple projects and tasks
  • At least 5 year experience managing multi-functional teams.
  • Demonstrated advanced English and Chinese language skills, both written and oral.
  • Ability to develop strong working relationships with other QS/QA responsible persons from the different regions withinorganization
  • Demonstrated excellent skills in analysis, innovative problem solving, communication, influencing,  and negotiation