Lead and enhance QMS and commercial quality operations across SE Asia and India. Oversee product quality, regulatory conformance, qualification/validation, audit readiness, CAPA, complaint handling, labelling/repacks, continuous improvement, risk management, cluster quality organization development, budgeting, and team capability building while partnering cross-functionally and engaging regulators.
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Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
People LeaderAll Job Posting Locations:
Singapore, SingaporeJob Description:
DePuy Synthes is recruiting for a Sr. Manager, ASEAN Lead located in Singapore, Central Singapore or Selangor, Malaysia.Key responsibilitiesThis 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.
- 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.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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#DePuySynthesCareers
Required Skills:
Preferred Skills:
Compliance Management, Continuous Improvement, Corrective and Preventive Action (CAPA), Developing Others, Fact-Based Decision Making, Give Feedback, Inclusive Leadership, ISO 9001, Leadership, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Processes, Quality Standards, Standard Operating Procedure (SOP), Team ManagementJohnson & Johnson Singapore, Singapore, SGP Office
1 Fusionopolis Way, Singapore, Singapore, Singapore, 138632
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