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Commercial Quality Associate Manager
Johnson & Johnson. Drive the implementation, maintenance, and continuous improvement of the China Commercial Quality Management System (QMS) .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Management Systems (QMS) within regulated environments, ensuring compliance with GxP regulations and driving continuous improvement initiatives. Proficient in data governance, CAPA management, and stakeholder collaboration to enhance operational efficiency and quality performance.
Highest-signal resume keywords
Quality Management Systems (QMS)GMP, GDP, GSP ComplianceCAPA ManagementData GovernanceDigital Transformation Initiatives
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Systems ManagementDocument ManagementData IntegrityAnalytical ThinkingProblem-SolvingProject ManagementChange ManagementRisk AssessmentsLean MethodologiesContinuous Improvement
Soft Skills
Excellent CommunicationStakeholder ManagementLearning Agility
Tools & Technologies
Computerized SystemsData Quality ManagementBusiness Process Automation
Certifications & Qualifications
Licensed Pharmacist
Industry Keywords
PharmaceuticalHealthcareMedical DeviceRegulated IndustriesALCOA+ Principles
About the role
Key responsibilities & impact- Drive the implementation, maintenance, and continuous improvement of the China Commercial Quality Management System (QMS)
- Ensure quality system processes comply with applicable GxP regulations, company standards, and business requirements
- Support deviations, CAPA, change controls, audits, inspections, document management, and training compliance
- Monitor quality performance indicators and identify improvement opportunities through trend analysis and risk-based decision making
- Lead or support digital transformation initiatives improving compliance, data quality, operational efficiency, and user experience
- Partner with business, quality, and technology stakeholders to identify automation and process simplification opportunities
- Support computerized system lifecycle activities, including implementation, upgrades, validation, UAT, and change management
- Manage Commercial Quality training programs and oversee quality document lifecycle management
- Establish and maintain data governance practices and ensure compliance with ALCOA+ principles
- Support business continuity, inspection readiness, and regulatory compliance through quality documentation, master data, and critical business information management
- Collaborate with global and local stakeholders on data standardization, reporting, and data governance
- Participate in and lead local, regional, and global quality projects and transformation programs
- Support investigations, root cause analysis, risk assessments, CAPA implementation, audits, inspections, and health authority interactions
- Identify process improvements using Lean and continuous improvement principles
- Foster quality, innovation, accountability, and continuous learning
Requirements
What you’ll need- 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
- Licensed Pharmacist certification is preferred
- Experience in commercial quality or distribution quality operations is preferred
- Experience supporting or leading digital transformation initiatives is preferred
- Experience with computerized systems, system implementations, validation activities, or business process automation is preferred
- Experience with Lean, Continuous Improvement, Operational Excellence, or related methodologies is preferred
- Exposure to global or regional projects and cross-functional collaboration is preferred
Benefits
Comp & perks- Inclusive work environment
- Employee respect, diversity, and dignity
- Merit recognition