Maharashtra, India
Hybrid
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Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
People LeaderAll Job Posting Locations:
Pune, Maharashtra, IndiaJob Description:
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.
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THE OPPORTUNITY
The Director, Quality Assurance, Regulatory Affairs, Distribution and Operations provides 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.
This position is a key member of the international QARA leadership team and partners closely with Global QARA, Commercial, Operations, and Supply Chain leaders. The role has a significant impact on patient safety, compliance outcomes, and the long‑term success 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 for country‑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, ensuring timely, 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:
Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline.
12+ years of progressive experience in Quality Assurance and/or Regulatory Affairs within medical devices or other highly regulated industries.
Demonstrated experience leading multi‑country or regional QARA portfolios, preferably across APAC markets.
Strong working knowledge of international and local regulatory frameworks and quality management system requirements.
Proven ability to develop and execute quality and regulatory strategies aligned with business objectives.
Experience operating effectively in a global, matrixed organization with senior executive stakeholder engagement.
Strong leadership presence, sound judgment, and decision‑making capabilities in complex regulatory and quality environments.
Desirable:
Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field.
Experience supporting International or 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 record of developing high‑performing regional leadership teams.
Other:
Language: English required; additional APAC languages preferred.
Travel: Moderate international travel across APAC markets.
Certifications: RAC or equivalent certification preferred.
COMPANY CULTURE
Competitive remuneration package.
Continuous training and support.
Award-winning leadership development programs.
Inclusive, flexible, and accessible working arrangements.
Equal opportunity employer supporting diversity and inclusion.
WHY CHOOSE US:
Competitive remuneration package and continuous training.
Supportive environment with award-winning leadership development programs.
Inclusive, flexible, and accessible working arrangements for all.
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.
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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 PlanningWant to know if this job is worth applying to?