Customer Focus:

·      Lead/ Collaborate with cross functional leaders across the company to drive standardization of best practices in the R&D area.

·      Provide R&D PV QA oversight of the Oncology and Specialty Medicine portfolios, clinical, non-clinical and precision medicine programs, MA program and PV activities across the DS CN organization, in

alignment with the business strategy.

·      Attends relevant local senior level internal(including cross-functional leadership meeting such as R&D, Corporate compliance as applicable etc) and external meetings where QA input is required as assigned by Head of R&D Quality (APAC).

·      Provide a Quality by Design (QbD) and Continuous Improvement strategy for R&D PV QA and the R&D clinical programs, MA program, PV activities and non-project initiatives across the DS CN organization. Supporting applicable GCP and GvP quality and compliance standards/requirements and their implementation.

·      Contribute to Quality Agreement for CRO partners to ensure that the terms of operation with external and RD QA meets company expectations and regulatory requirements. Further ensure proper quality oversight and escalation of issues / incidences specifically as it relates to the support functions impacting the QA teams such as 3rd parties/vendors/outsourced activities.

Leadership and Team Management

·      Ensure employees have a clear understanding of the connection between their contributions and the Enterprise and Management Unit goals. Enhance collaboration and buy-in on the goals and deliverables due to increased clarification of expectations.

·      Foster efficient use of resources and direct efforts to accomplish more. Identify resources and collaboration needed to accomplish work by driving alignment within DS RD PV MA QA teams and

among the stakeholders regarding goals

·      Promote an environment that thrives on accountability, agility, innovation, and proactive quality. Drive

employee engagement, mentoring, coaching and performance management; Exhibit servant leadership while driving results.

Country QA Oversight:

·      Provide country QA support closely aligned with the business strategy. Support the global and regional quality annual objectives,

strategic initiatives to deliver against the local business plan.

·      Oversight and maintain Quality management System (QMS) in the country in alignment with the business strategy. Provide strategic direction pertinent to non-compliance/quality events and organizational process risks not only for internal QA team (global/ local), but also to:

o   Global / LocalMedical Affairs

o   Global / Local Project Teams

o   Global / Local Clinical Operations team

o   Clinical Safety and Pharmacovigilance

o   Companion Diagnostics/ Device

o   Vendors/ CRO

o   Others

·      Ensure adequate liaison with legal and compliance with respect to third party relevant R&D activities, provide QA input as necessary.

·      In terms of regulatory inspections,

o   Provide guidance to DS CN organization on inspection readiness for Health Authority inspections

locally; may be assigned Inspection Management Team / Lead roles in support of inspection management preparation, facilitation, and post inspection-related activities.

o  Accountable for inspection preparation and management for the respective R&D clinical programs (and MA program and PV activities as applicable) in alignment with regulatory and development strategies.

o  Act as management representative for all local health authority inspections, specifically where RD is in question. Develop and maintain an effective working relationship with relevant HAs. Ensure that compliance commitments are fulfilled on time.

Quality Management and Continuous Improvement:

·      Drive standardization and process improvement initiatives across RD Quality and in close collaboration with internal and external stakeholders.

·      Provide leadership oversight and guidance during the development and execution of Corrective and Preventive Actions (CAPAs) in DS China. Ensure adequate CAPAs are defined, implemented, and closed in a timely manner through providing guidance and facilitation of quality event resolution.

·      Review risks by evaluating Quality Events, audit and inspection outcomes, data interpretation, and deliver the risk areas/process of improvement to our stakeholders via the QMS scheme (i.e., Quality Management Review, Quality Review Board) across the R&D, PV and MA organization

leaders and relevant external stakeholders.

·      Oversee/Lead formal investigations of quality issues as they arise, ensuring timely escalation to line management of major and/or critical incidences and in collaboration with other QA line function (QA GxP audits, QA Standards and Procedures).

·      Identify ways to continuously improve quality and compliance with regulations and company standards, policies and procedures through partnership with internal and external stakeholders.

·      Ensure adequate and effective lessons learned from audit, regulatory authority inspections and internal process deviations are delivered to program teams.

External Engagement

·      Contribute, help shape the associated external regulatory environment through participation in industry wide activities to assure the needs of the company are proactively established and that innovative

approach to solutions are in place.

·      Continuously review compliance metrics trends from regulators/ industry experts and align/ develop the RD QA strategic road map to meet changing regulatory and business needs.

·      Drive effective relationship with alliance partners, collaborators, vendors, and other key company partners to ensure a culture of compliance at all levels

Other duties may be assigned.

Requirements:

• Minimum Bachelor in Life Science related discipline
• Minimum 15 years’ experience working in the bio/pharmaceutical industry or drug development R&D related organizations/institutions; and/or at least 6 years of experience working in the GxP/GvP/GLP environment in line management capacity.
• Experience in R+D, QMS, GCP/PV/GLP Inspections, Audit, Issue and/or Risk Management and Vendor Management is preferred.
• Experience in leading people, change and/or organizational transformation.
• A subject matter expert in relevant local and international ICH E6 GCP and GvP related regulations/guidelines.
• Experience in working in international and matrixed reporting global environment; value the importance of teamwork and drive effective relationship with alliance partners, collaborators, vendors, and other stakeholders.
• Demonstrated expertise to build relationships with a culturally diverse group of internal and external stakeholders to influence outcomes.
• Strong communication skills (interpersonal, verbal, and written); especially respect and understanding of cultural diversity and diplomatically address sensitive issues confidentially and professionally.
• Ability to think critically, analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations, to various stakeholders.
• Ability to lead team/project and work flexibly and independently; and adjust to changing priorities and unforeseen event in a fast-paced environment.
• Experience in managing functional budget, create and maintain strategic roadmap, metrics and effective organization.
• Ability to travel up to 20%.
• Fluent in Chinese and English language skill (written and verbal)
• Proficient in MS Office 365/ MS Teams