Head of R&d Quality

**Job Objectives:
This position is accountable to drive a proactive approach to quality and instilling a shared passion for building a stronger Quality organization with One Quality voice as the best trusted quality partner with internal and external stakeholders. This role is including, instilling a consistent quality mindset and culture through partnering with stakeholders to streamline the product lifecycle process and develop risk mitigation strategies.

Provide quality oversight and strategic quality advice to the Oncology and Specialty Medicine portfolios, clinical, non-clinical and precision medicine programs, Pharmacovigilance (PV) activities, Medical Affair (MA) Program (i.e., Phase IV, EAP, IIS, and Post Marketing requirement studies) across the DSG organization, lead the DSG inspection management activities, 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 DSG organization, 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.

The incumbent will be responsible for developing the local QMS for the pharmaceutical development, MA and PV organizations and will partner with business leaders across the organization to define and align on strategic priorities and emerging business changes.

The role will manage Global R&D and PV QA resources (Asia Pacific: Country QA in China, Korea, Taiwan, Singapore and other Country QA if applicable) in an efficient and effective manner including, but not limited to oversight of defined work products, coaching and mentoring of global team, performance management and contributing to organizational efficiencies.

**Job Responsibility:
**1. Customer Focus**:

- 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 DSG organization, in alignment with the business strategy.
- Lead the DSG inspection management activities by ensuring continued submission, compliance and inspection preparedness for the respective R&D clinical programs, MA program and PV activities in alignment with regulatory and development strategies.
- Act as management representative for all key health authority inspections (MFDS, Taiwan FDA, PMDA, Other Asia Health Authority etc.). May act as point person for local regulation training as applicable.
- 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 DSG organization
- 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.
- Ensure adequate CAPAs are defined, implemented, and closed through providing guidance and facilitation of quality event resolution
- Proactively ensure that all functions consistently operate in a state of compliance.
- May execute audits and Inspections across APAC region and in cross collaboration with QA line function as necessary.

**2. Oversight**:

- Oversight and maintain Quality management System (QMS) in each Asia-Pacific 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:

- Global / Local Medical Affairs
- Global / Local Project Teams
- Global / Local Clinical Operations team
- Clinical Safety and Pharmacovigilance
- Companion Diagnostics/ Device
- Vendors/ CROs

**3. Leadership/ team management**:

- Create a high performing team environment and a cohesive culture driven by values of integrity, respect, and culture of speak up
- Lead and hold others accountable to performance, talent, and development objectives
- Create an environment that fosters diversity of thoughts, inclusivity and one that adheres to the principals set forth in the organization (JOIN, GROW, THRIVE)
- Create an environment that thrives on innovation, proactive quality and is disciplined to efficiently execute against pre-defined deliverables
- Drive employee engagement, mentoring, coaching and performance management
- Exhibit servant leadership while driving results.

**4. External Engagement**:

- Contribute, help shape the associated external regulatory environment through participation in industry wide organizations to assure the needs of the company are proactively established and tha