Sr. Manager, QARA China Ops & Dist.

DePuy Synthes is recruiting for a Sr. Manager QARA China Ops & Dist. locatedin Shanghai.

TheSr. Manager QARA China Ops & Dist.provides senior operational leadership for quality assurance and regulatory affairs supporting China operations anddistributionbasedmarket 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.

• Partnerwith crossfunctional 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 andparticipatein audits inspections and health authority interactions related to China operations and distribution activities.

• Drive continuous improvement initiatives to enhance QARA compliance efficiencyinspectionreadiness and operational effectiveness.

• Define distributor markets and design processes and systems that enable an efficient Distribution Management structure.

Qualifications

Education

• Required: Bachelors degree in Regulatory Affairs Life Sciences Engineering Business ora relateddiscipline.

• Preferred: Advanced degree or professional certification in Regulatory Affairs Quality ora relatedfield.

Experience and Skills

Required:

• 810 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 distributorbased or hybrid operating models.

• Demonstrated ability to manage complex stakeholder environments and crossfunctional collaboration in matrixed organizations.

• Experience supporting audits inspections and regulatory or compliance assessments.

Preferred:

• Experience supporting multimarket 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 riskmanagement and problemsolving skills.

• Effective written and verbal communication skills with the ability to influence stakeholders.

Other

• Language: Mandarin and English.

• Travel: Moderate domestic and occasional international travel.

• Certifications: RAC or equivalent preferred but not.

For more information on how we support the whole health of our employees throughout their wellnesscareerand life journey please visit.

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 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.