Senior Manager, QMS & HSD (SE Asia & India)

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Job Function:
Quality

Job Sub Function:
Customer/Commercial Quality

Job Category:
People Leader

All Job Posting Locations:
Singapore, Singapore

Job Description:
DePuy Synthes is recruiting for a Sr.

Manager, ASEAN Lead located in Singapore, Central Singapore or Selangor, Malaysia.

Key responsibilities
This role works closely with the respective QARA leadership teams to drive Quality & Compliance strategies and support DePuy Synthes business priorities across SE Asia and India.

The role is accountable for quality management systems and commercial quality operations across SE Asia and India.


* Quality Management System and Compliance
Lead the implementation, maintenance, and ongoing enhancement of local marketing company quality management systems across SE Asia and India.

The scope includes proactive quality oversight, new product introduction, product importation, change control, deviations, CAPA, labelling requirements, commercialization, product release, distribution, complaint handling, adverse event reporting, quality performance reviews, escalations, and field action execution.


* Product Quality and Regulatory Conformance
Maintain oversight to ensure that product quality and performance remain aligned with company requirements and applicable regulatory standards in each operating market.


* Qualification, Validation, and Quality Control Support
Oversee qualification and validation activities for applicable products and processes, together with related quality control support activities.


* Audit Readiness and Compliance Assurance
Maintain compliance with relevant quality standards and regulatory requirements by managing internal and external audits, confirming compliance status, identifying gaps, and driving required improvement actions.


* Quality Performance and Continuous Improvement
Use relevant analytics, tools, and reporting to monitor quality performance and advance continuous improvement.

Lead or sponsor improvement initiatives, track legal and regulatory developments that may affect the business, and build cross-functional collaboration to strengthen quality and co...