Senior Manager, QMS & HSD (SE Asia & India)
Johnson & Johnson
- Location
- Singapore, Singapore
- Work model
- On-Site
- Level
- Senior
- H-1B history
- 2 approvals (FY2023)
- Posted
- 12h ago
About this role
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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 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