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Job Function:
Quality
Job Sub Function:
Customer/Commercial Quality
Job Category:
People Leader
All Job Posting Locations:
North Ryde, New South Wales, Australia
DePuy Synthes is recruiting for a Director, Quality Assurance, Regulatory Affairs, Distribution and Operations, APAC in North Ryde, Australia or Shanghai, China, Maharashtra, India, or Seoul, Korea.
THE OPPORTUNITY
TheDirector, Quality Assurance, Regulatory Affairs, Distribution and Operationsprovides enterprise‑level leadership for quality assurance and regulatory affairs across the Asia‑Pacific region. With accountability for local market regulatory compliance, quality management system execution, and sustainable market access, this role shapes and executes the regional QARA strategy in alignment with global priorities.
Thisposition is a key member of the international QARA leadership team and partners closely with Global QARA, Commercial, Operations, and Supply Chain leaders.Therole has a significant impact on patient safety, compliance outcomes, and thelong‑termsuccess of the APAC portfolio across diverse and highly regulated markets.
RESPONSIBILITIES
Lead and execute the APAC Quality Assurance and Regulatory Affairs strategy in alignment with global QARA objectives and international business priorities.
Provide executive oversight forcountry‑specific regulatory submissions, approvals, renewals, variations, and lifecycle management activities across APAC markets.
Ensure ongoing compliance with regional and local regulatory requirements, quality management system standards, and internal policies and procedures.
Serve as the senior escalation point for APAC QARA issues, including regulatory risk, quality system gaps, and health authority interactions.
Partner with Commercial, Operations, Supply Chain, Legal, and Global QARA leaders to support product launches, supply continuity, and portfolio optimization.
Monitor, interpret, and communicate emerging regulatory and quality trends across APAC, proactively assessing business, compliance, and patient safety impact.
Oversee and support regulatory inspections, quality audits, and health authority engagements, ensuringtimely, consistent, and effective responses.
Lead, develop, and mentor APAC QARA leaders and teams, building strong succession pipelines, capability, and performance across the region.
Drive continuous improvement, simplification, and harmonization of quality and regulatory processes across APAC local markets.
Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth.
Define distributor markets and design processes and systems that enable an efficient Distribution Management structure.
ABOUT YOU
Required:
Desirable:
Experience supportingInternationalor emerging market regulatory and quality operating models.
Direct experience leading regulatory inspections, quality audits, and negotiations with APAC health authorities.
Demonstrated success driving quality or regulatory transformation, simplification, or operating model change.
Experience within orthopedics, medical devices, or healthcare manufacturing environments.
Track recordof developing high‑performing regional leadership teams.
Other:
Language: Englishrequired;additionalAPAC languages preferred.
Travel: Moderate international travel across APAC markets.
Certifications: RAC or equivalent certification preferred.
COMPANY CULTURE
WHY CHOOSE US:
Johnson & Johnson has announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company. The planned separation is anticipated to be completed within 18 to 24 months, subject to satisfaction of legal and regulatory requirements, 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 the standalone orthopaedics company and your employment would be governed by the standalone orthopaedics company’s employment processes, programs, policies and benefit plans. In that case, details of any planned changes would be provided to you by the standalone orthopaedics company 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.
#LI-Hybrid
#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), Succession Planning
At Johnson & Johnson, we believe health is everything. As a focused healthcare company, with expertise in Innovative Medicine and MedTech, we’re empowered to tackle the world’s toughest health challenges, innovate through science and technology, and transform patient care.
All of this is possible because of our people. We’re passionate innovators who put people first, and through our purpose-driven culture and talented workforce, we are stronger than ever.
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