Associate Director, Development and Medical QA (Asia)

The Associate Director is responsible for driving a proactive approach to operationalize the Development and Medical QA mission and strategy, and work in close collaboration with the Head of Development and Medical QA (Asia Pacific) to translate quality strategy into practical execution, drive risk-based quality oversight, and strengthen quality culture across Asia organization.

JOB DESCRIPTION

- Act as a trusted QA partner to Clinical and Medical Affairs stakeholders by providing proactive quality advice, risk assessment and oversight.

- Instill a consistent mindset and culture through partnering with stakeholders to streamline the product lifecycle process by embedding proactive quality approach.

- Quality by Design (QbD) and supporting risk-based decision making, developing risk mitigation strategies across projects and initiatives.

- Lead and support inspection readiness and management activities, including acting as Inspection Management Team Lead and coordinating pre- and post-inspection activities.

- Lead formal investigations of issues as they arise, ensuring timely escalation to line management if critical incidences are not resolved in due course.

- Provide guidance during the root cause analysis and development and execution of Corrective and Preventive Actions (CAPAs).

- Collaborate with Head of Development and Medical QA (Asia Pacific) to monitor and analyze quality risks and trends (e.g., quality events, audits, inspections), and drive continuous improvement actions.

- Contribute to the enhancement of the local QMS by aligning processes with regulatory requirements, global standards, and evolving business needs.

- Provide proactive quality support aligned with business strategy, including consultation and guidance on quality-related concerns, resolution of vendor-related issues identified for the assigned studies.

- Execute quality oversight activities by embedding Quality by Design (QbD) principles across the product/clinical trial lifecycle in collaboration with Head of Development and Medical QA (Asia Pacific) to translating QA strategy into operational practice.

- Support implementation of applicable GxP and regulatory requirements in day-to-day activities, ensuring compliance while partnering with stakeholders to address operational needs.

- Contribute to the delivery of global and regional QA objectives and strategic initiatives by supporting local execution and aligning with Head of Development and Medical QA (Asia Pacific) priorities and business needs.

- Drive implementation of program-specific quality plans, ensuring alignment of business priorities with quality oversight and deliverables.

- Lead or support preparation and management of regulatory inspections as assigned by Head of Development and Medical QA (Asia Pacific).

- Coordinate pre-inspection activities, including document readiness, stakeholder preparation, training, and mock inspections when applicable.

- Act as QA representative and/or point of contact during inspections, supporting interactions with health authorities as appropriate.

- Support inspection responses, including observation management, root cause analysis, and CAPA development and follow-up.

- Lead or support Quality Event (QE) management activities, including deviation reporting, investigation, root cause analysis (RCA), and CAPA development.

- Ensure appropriate escalation, criticality assessment, and tracking of QEs in alignment with QMS requirements.

- Support monitoring of QE trends and contribute to continuous improvement through lessons learned and risk mitigation actions Business Partnering.

- Act as a key QA partner to local stakeholders (e.g., Clinical, Medical Affairs), providing practical and solution-oriented quality advice.

- Serve as a liaison between local teams and global/regional QA functions to ensure alignment and effective communication.

- Collaborate with relevant QA functions (e.g., Audits & Compliance, PV/MA QA, QMS) to ensure consistency of quality and compliance activities.

- Support implementation and maintenance of the local QMS in alignment with global standards and Head of Development and Medical QA (Asia Pacific) direction in partnership with the relevant business function in DSTW.

- Contribute to the development and continuous improvement of local QA frameworks (e.g., QA Manual, Quality Gate processes).

- Support monitoring of compliance metrics, evaluate quality risks through analysis of Quality Events, audit and inspection outcomes, and relevant data communicate key risk areas and improvement opportunities to stakeholders via QMS forums (e.g. Quality Management Board).

- Support business stakeholders on local SOP management, including review/approve deviations as appropriate.

- Promote a proactive quality culture through training, workshops, and stakeholder engagement activities.

- Deliver or support training delivery as appropriate.

- Ensure lessons learned from audits, inspections, and quality events are effectively communicated and embedded into operations.

- Identify and support continuous improvement initiatives to enhance quality and compliance in collaboration with stakeholders.

- Support local SOP lifecycle activities (e.g., creation, review, update, and deviation management) as assigned.

- This role is dedicated to activities in the assigned territories in APAC but may be assigned to support any global activities to support R&D PVQA objectives as deemed necessary.

JOB REQUIREMENTS

- Bachelor's Degree or Master's Degree in scientific, healthcare, or related discipline and/or background in Medical Health Profession (RN, Medical technologist, etc.).

- 15 years of Working Experience in scientific, health care, or related discipline.

- Strong experience in managing many aspects of quality in an international, global/regional context in a regulated healthcare environment.

- Experience in Pharmaceuticals, Medical Device, Vaccines, Diagnostics, Generics/Consumer products.

- Experience working directly with Global / Regional / Local Health Authorities (MFDS, TFDA, CFDA, PMDA, US FDA and MHRA) is advantageous.

- Working knowledge of the end-to-end Drug development process in R&D PV and MA space. 

- Strong therapeutic experience specifically Oncology and all other therapeutic experiences is preferred. 

- Building open and honest relationships, promoting collaborations with stakeholders to understand their needs and expectations.

- Provide constructive feedback and develop others to succeed and achieve goals.

- Demonstrate a strong sense to achieve goals through commitment and effective execution of work process.

- Understand, develops, and promote effective quality and regulatory process across various countries and coordinate appropriately with regional business expectations.

- Solves problems and applies analytical approach to arrive to decisions.

- Gain stakeholder commitment, effective relationship building and conflict management, present compelling case for ideas and initiatives through thoughtful strategy to gain a favourable outcome.