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We are seeking a highly motivated quality professional to join our China Commercial Quality organization as an Associate Manager, China Commercial Quality.

DESCRIPTION

This role plays a critical part in ensuring compliance, operational excellence, and business continuity through effective Quality Management System (QMS) governance, training and document management, digital transformation initiatives, and global project support.

The successful candidate will have the opportunity to work across local, regional, and global teams, driving quality excellence while supporting the organization's future transformation agenda through data-driven and digital solutions.

RESPONSIBILITIES

Quality Systems Management

• Drive the implementation, maintenance, and continuous improvement of the China Commercial Quality Management System (QMS).
• Ensure quality system processes remain compliant with applicable GxP regulations, company standards, and business requirements.
• Support key quality processes including deviations, CAPA, change controls, audits, inspections, document management, and training compliance.
• Monitor quality performance indicators and identify opportunities for improvement through trend analysis and risk-based decision making.

Digital Transformation & Innovation

• Lead or support digital transformation initiatives aimed at improving compliance, data quality, operational efficiency, and user experience.
• Partner with business, quality, and technology stakeholders to identify automation opportunities and process simplification initiatives.
• Support computerized system lifecycle activities, including implementation, upgrades, validation, user acceptance testing (UAT), and change management.
• Promote data-driven decision making by leveraging quality and operational data to support continuous improvement.

Training, Documentation & Data Governance & Data Integrity

• Manage Commercial Quality training programs to ensure qualification and training compliance across the organization.
• Oversee document lifecycle management, ensuring the creation, review, approval, retention, archival, and retrieval of quality documents and records in accordance with regulatory and company requirements.
• Establish and maintain robust data governance practices to ensure data accuracy, consistency, completeness, traceability, and integrity across quality systems and business processes.
• Ensure quality records and data comply with ALCOA+ principles and applicable regulatory requirements.
• Support business continuity, inspection readiness, and regulatory compliance through effective management of quality documentation, master data, and critical business information.
• Collaborate with global and local stakeholders to improve data standardization, data lifecycle management, reporting capabilities, and data governance processes.

Global & Regional Project Support

• Participate in and lead local, regional, and global quality projects and transformation programs.
• Collaborate with cross-functional and cross-regional stakeholders to ensure successful delivery of project objectives.
• Support organizational initiatives related to digitalization, process excellence, simplification, and capability development.

Compliance & Inspection Readiness

• Support investigations, root cause analysis, risk assessments, and CAPA implementation related to quality events and compliance issues.
• Contribute to internal audits, external inspections, and health authority interactions.
• Maintain a strong inspection readiness mindset and support sustainable compliance efforts.

Continuous Improvement

• Identify opportunities to streamline processes, eliminate waste, and improve operational effectiveness using Lean and continuous improvement principles.
• Foster a culture of quality, innovation, accountability, and continuous learning.

REQUIRED QUALIFICATIONS

• Bachelor's degree or above in Pharmacy, Pharmaceutical Sciences, Life Sciences, Chemistry, Engineering, Quality Management, or a related discipline.
• Minimum 5 years of experience in pharmaceutical, healthcare, medical device, or other regulated industries.
• Strong experience in GMP, GDP, GSP, Quality Systems Management, Quality Operations, or Compliance functions within a multinational environment.
• Demonstrated experience supporting audits, inspections, CAPA management, and quality system processes.
• Strong project management and stakeholder management skills.
• Excellent communication skills in both English and Chinese.
• Strong analytical thinking, problem-solving ability, and learning agility.
• Ability to work effectively in a global matrix organization.
• Experience in document management, data governance, data integrity, and quality data management within a regulated GxP environment is highly desirable.
• Good understanding of Data Integrity requirements and ALCOA+ principles and their application in quality systems, documentation, computerized systems, and quality records management.

PREFERRED QUALIFICATIONS

• Licensed Pharmacist certification.
• Experience in commercial quality or distribution quality operations.
• Experience supporting or leading digital transformation initiatives.
• Experience with computerized systems, system implementations, validation activities, or business process automation.
• Experience with Lean, Continuous Improvement, Operational Excellence, or related methodologies.
• Exposure to global or regional projects and cross-functional collaboration.

KEY COMPETENCIES

• Quality Systems Leadership
• Digital Mindset
• Process Excellence
• Data Analytics & Data Governance
• Continuous Improvement
• Project Management
• Stakeholder Management
• Change Management
• Cross-functional Collaboration
• Learning Agility
• Strategic Thinking
• Business Partnership

Required Skills:

Preferred Skills: