Description
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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Shanghai, ChinaJob Description:
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.DePuy Synthes is recruiting for a Sr. Manager, QARA China Ops & Dist. located in Shanghai.
The Sr. Manager, QARA China Ops & Dist. provides senior operational leadership for quality assurance and regulatory affairs supporting China operations and distribution‑based market models. This role is accountable for ensuring regulatory compliance, effective quality management system execution, distributor governance, and uninterrupted supply in one of DePuy Synthes’ most complex and strategically important markets.
This role plays a critical part in managing quality and regulatory risk, enabling sustainable market access, and supporting compliant business growth. The Sr. Manager partners closely with China country leadership, Global QARA, Supply Chain, Commercial, and Operations teams to ensure patient safety and operational excellence.
Key Responsibilities
Lead and manage Quality Assurance and Regulatory Affairs activities supporting China operations and distribution models in alignment with global QARA objectives.
Ensure compliance with China regulatory requirements, distributor governance obligations, internal policies, and DePuy Synthes quality management system standards.
Serve as a senior QARA point of contact for China Operations & Distribution.
Partner with cross‑functional teams including Regulatory Affairs, Quality, Supply Chain, Commercial, Operations, and Legal to support product availability, launches, and supply continuity.
Support distributor onboarding, oversight, and performance management from a quality and regulatory compliance perspective.
Monitor regulatory, quality, and operational changes in China and assess potential impacts to products, portfolios, and business operations.
Support and participate in audits, inspections, and health authority interactions related to China operations and distribution activities.
Drive continuous improvement initiatives to enhance QARA compliance, efficiency, inspection readiness, and operational effectiveness.
Define distributor markets and design processes and systems that enable an efficient Distribution Management structure.
Qualifications
Education
Required: Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, Business, or a related discipline.
Preferred: Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field.
Experience and Skills
Required:
8–10 years of progressive experience in Quality Assurance, Regulatory Affairs, operations, or distribution support roles within a highly regulated industry.
Strong working knowledge of China regulatory requirements, operational compliance expectations, and distributor‑based or hybrid operating models.
Demonstrated ability to manage complex stakeholder environments and cross‑functional collaboration in matrixed organizations.
Experience supporting audits, inspections, and regulatory or compliance assessments.
Preferred:
Experience supporting multi‑market QARA portfolios.
Experience working in multinational or global organizations.
Background in medical devices, orthopedics, healthcare manufacturing, or other highly regulated industries.
Demonstrated success contributing to process improvement, operational transformation, or compliance simplification initiatives.
Regulatory Affairs or Quality certification (e.g., RAC or equivalent).
Strong analytical, risk‑management, and problem‑solving skills.
Effective written and verbal communication skills with the ability to influence stakeholders.
Other
Language: Mandarin and English required.
Travel: Moderate domestic and occasional international travel.
Certifications: RAC or equivalent preferred but not required.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
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:
Analytical Reasoning, Business Writing, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical CredibilityDePuy Synthes is recruiting for a Sr. Manager, QARA China Ops & Dist. located in Shanghai.
The Sr. Manager, QARA China Ops & Dist. provides senior operational leadership for quality assurance and regulatory affairs supporting China operations and distribution‑based market models. This role is accountable for ensuring regulatory compliance, effective quality management system execution, distributor governance, and uninterrupted supply in one of DePuy Synthes’ most complex and strategically important markets.
This role plays a critical part in managing quality and regulatory risk, enabling sustainable market access, and supporting compliant business growth. The Sr. Manager partners closely with China country leadership, Global QARA, Supply Chain, Commercial, and Operations teams to ensure patient safety and operational excellence.
Key Responsibilities
Lead and manage Quality Assurance and Regulatory Affairs activities supporting China operations and distribution models in alignment with global QARA objectives.
Ensure compliance with China regulatory requirements, distributor governance obligations, internal policies, and DePuy Synthes quality management system standards.
Serve as a senior QARA point of contact for China Operations & Distribution.
Partner with cross‑functional teams including Regulatory Affairs, Quality, Supply Chain, Commercial, Operations, and Legal to support product availability, launches, and supply continuity.
Support distributor onboarding, oversight, and performance management from a quality and regulatory compliance perspective.
Monitor regulatory, quality, and operational changes in China and assess potential impacts to products, portfolios, and business operations.
Support and participate in audits, inspections, and health authority interactions related to China operations and distribution activities.
Drive continuous improvement initiatives to enhance QARA compliance, efficiency, inspection readiness, and operational effectiveness.
Define distributor markets and design processes and systems that enable an efficient Distribution Management structure.
Qualifications
Education
Required: Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, Business, or a related discipline.
Preferred: Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field.
Experience and Skills
Required:
8–10 years of progressive experience in Quality Assurance, Regulatory Affairs, operations, or distribution support roles within a highly regulated industry.
Strong working knowledge of China regulatory requirements, operational compliance expectations, and distributor‑based or hybrid operating models.
Demonstrated ability to manage complex stakeholder environments and cross‑functional collaboration in matrixed organizations.
Experience supporting audits, inspections, and regulatory or compliance assessments.
Preferred:
Experience supporting multi‑market QARA portfolios.
Experience working in multinational or global organizations.
Background in medical devices, orthopedics, healthcare manufacturing, or other highly regulated industries.
Demonstrated success contributing to process improvement, operational transformation, or compliance simplification initiatives.
Regulatory Affairs or Quality certification (e.g., RAC or equivalent).
Strong analytical, risk‑management, and problem‑solving skills.
Effective written and verbal communication skills with the ability to influence stakeholders.
Other
Language: Mandarin and English required.
Travel: Moderate domestic and occasional international travel.
Certifications: RAC or equivalent preferred but not required.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
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
