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