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

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 compliance outcomes.

• Risk Management and Business Partnership
  Partner with business functions and management to shape and execute strategies that embed early risk assessment, mitigation planning, and compliant solutions for business growth opportunities.

• Cluster Quality Organization and Product Handling
  Guide the development of the cluster quality organization in line with quality and compliance objectives. Enhance and sustain robust product handling processes, including labelling and repacking activities.

• Budget and Resource Planning
  Support management in developing, planning, and maintaining organizational budgets and resource requirements.

• Team Development and Capability Building
  Build leadership strength, technical expertise, and current and future team capabilities needed to support business priorities.

• Other Responsibilities
  Carry out other assigned duties and responsibilities as required.

Qualification:

• A bachelor’s degree in Science, Engineering, or a related discipline is required. An advanced degree or postgraduate studies in Science, Engineering, Business, or an equivalent field is preferred. Candidates should possess a broad business background, ideally with experience across multiple product categories, and strong quality and regulatory compliance expertise in areas such as market quality, quality operations, and quality systems.

• A minimum of 10 years of progressively responsible experience within a regulated industry is required. The successful candidate will have demonstrated achievements in business partnership, strategic planning, project management and execution, change management, and the application of quality and regulatory compliance principles throughout the product lifecycle, from development and manufacturing through distribution and engagement with customers and health authorities.

• Demonstrated experience engaging with regulatory authorities, notified bodies, and other external stakeholders, with a proven track record of successfully addressing complex quality and regulatory compliance challenges through effective cross-functional collaboration.

• The role requires the ability to drive strategic alignment across diverse regulatory environments, build consensus among stakeholders, and influence outcomes effectively. Strong project and people management capabilities, analytical and problem-solving skills, and exceptional leadership, coaching, and influencing abilities are essential. A commitment to inclusive leadership and the development of high-performing teams is also required.