Commercial Quality Associate Manager

在 Johnson & Johnson，我们相信健康就是一切。 我们在医疗创新方面的实力使我们能够建立一个能够预防，治疗和治愈复杂疾病的世界,在这个世界中,治疗更智能，侵入性更低,并且解决方案是个性化的。 凭借我们在创新医学和医疗技术方面的专业知识,我们处于独特的地位,能够在当今的全套医疗保健解决方案中进行创新,以实现未来的突破,并对人类的健康产生深远的影响。 如需了解更多信息，请访问jnj.com

在我们的信条指引下，强生公司对全球范围内与我们共事的员工负有责任。我们提供一个包容的工作环境，在这里每个人都被视为独立的个体。在强生，我们尊重员工的多样性和尊严，并认可他们的价值。

工作职能：Quality

作业子功能：Customer/Commercial Quality

职位类别：Professional

所有职位发布位置：Beijing, China, Xian, Shaanxi, China

职位描述：
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:
ISO 9001, 合规管理, 商业头脑, 基于事实的决策制定, 审计管理, 持续改进, 标准操作程序 (SOP), 沟通, 监管环境, 解决问题, 训练, 质量控制 (QC), 质量标准, 质量管理体系 (QMS), 问题上报