J&J Family of Companies Associate Director, Asia Pacific Strategy in Beijing, China

· Manage the development and maintenance of an integrated quality strategy to support AP and China R&D business-critical activities and compliance

· Work with risk owners across the region to develop effective risk mitigation plans to control risks identified

· Provide input into integrated quality plans (IQPs) (when requested) and the master audit schedule to ensure that issues identified from AP region are built into IQP risk mitigation plans as well as the overall risk based audit strategy

· Lead or assist in the early identification, escalation, and resolution of quality issues that pose a significant risk to achievement of core company objectives

· Proactively liaise with BRQC relevant strategy leaders to share issues identified in the AP region /China R&D and assure outcomes of key mitigation activities are communicated to relevant stakeholders, including management (as applicable)

· Work with BRQC Janssen QA domain leaders to share issues in the region and support the development of an audit schedule to address areas of key risk

· Collaborate with Regulatory Compliance to support inspection readiness activities to facilitate health authority submissions

oDevelop and execute pre-inspection readiness activities for internal Janssen R&D and external parties as directed by the AP Strategy Lead

oSupport GCP inspections in AP region including post-inspection commitments as assigned

· Contribute to 90-day risk mitigation plans following closure of a deal to license or acquire a product to support development of mitigation strategies and provide relevant information to the QP&S L&A Lead as requested

· Leverage quality analytics data, internal and external factors and contextualized key quality insights to provide quality consultancy to primary stakeholders

· Influence the regulatory environment in China/AP by commenting on key regulations in China/AP region, and engagement with external stakeholders in the development and interpretation of new regulations where appropriate.

Qualifications

• Ability to analyze and interpret data, derive insights, and determine root cause to adjudicate issues in the research and development process

• Ability to drive change management with peers and direct reports and business partners

• Disciplined approach to defining and addressing problems

• Organization, prioritization and time management

• Ability to create an open, inviting and creative environment

• Ability to work in a global environment

• Experience working with multidisciplinary and cross functional leaders from R&D, Medical Safety, Regulatory and Quality functions

• Proactive strategic thinker with strong problem solving skills

• Strong blend of both strategic and tactical approaches to quality and business objectives

Other required skills:

• Fluency in English is required

• Proficient in Microsoft Office applications, and able to work with a

variety of database and data analytics platforms

Primary Location

China-Beijing-Beijing

Organization

J&J (China) Investments Ltd A- Beijing Branch (7075)

Job Function

Compliance

Requisition ID

1700195878W