Global Pharma / CRO: (Associate) Director, GxP Quality Assurance, reporting to SG

【Position Summary】

• We are seeking an experienced (Associate) Director, Quality Assurance to provide strategic quality leadership and oversight for R&D and Pharmacovigilance (PV)-related activities in Taiwan.
• Based in the Taipei office, this position reports directly to the Head of Development & Medical QA (APAC), who is based in Singapore, and will work closely with regional and global Quality, Development, Medical, PV and other cross-functional stakeholders.
• The incumbent will play a critical role in driving a proactive, risk-based quality management approach, strengthening the local Quality Management System (QMS), supporting health authority inspections and audits, and embedding a sustainable quality culture across the organization.
• This is a highly regional and cross-functional role requiring regular interaction with APAC and global stakeholders. Frequent overseas business travel is required to support regional/global meetings, inspections, audits and other quality-related activities.

【Qualifications】

• Minimum 12 years of relevant experience in biotechnology, pharmaceuticals, drug development, R&D, or a related environment, including at least 8 years in GxP, GvP and/or GLP-regulated settings.
• Solid background in Quality Assurance, Quality Management, and/or Compliance, with experience managing complex quality matters and supporting cross-functional decision-making.
• Sound knowledge of the pharmaceutical R&D lifecycle, applicable quality standards, and regulatory requirements.
• Practical experience in several of the following areas is preferred:
  • R&D Quality Assurance
  • Quality Management Systems (QMS)
  • Health Authority Inspections
  • Internal / External Audits
  • Quality Events / Deviation Management
  • Risk Management
  • CAPA and Root Cause Analysis
  • Vendor / Supplier Quality Management
  • Pharmacovigilance Quality Assurance
• Experience in regulatory inspection readiness and inspection management is highly desirable.
• Proven track record of working effectively in regional, global, and cross-functional matrix organizations, with strong stakeholder management and influencing skills.
• Strong strategic judgment, risk assessment, problem-solving, and decision-making capabilities, with the ability to operate independently in a complex international environment.
• Excellent English and Chinese communication and presentation skills, with the ability to work effectively with the Singapore-based APAC manager and regional/global stakeholders.
• Willingness and ability to travel overseas frequently.

【Key Responsibilities】

• Drive a proactive, risk-based approach to quality and serve as a trusted Quality partner to internal and external stakeholders.
• Represent Quality in cross-functional leadership forums and provide strategic quality input to business and functional decision-making.
• Work closely with the Head of Development & Medical QA (APAC), based in Singapore, and Development leadership to implement R&D and PV QA strategies, priorities and initiatives in Taiwan.
• Partner with key stakeholders to foster a consistent quality mindset and culture, streamline product lifecycle processes, and establish appropriate risk mitigation strategies.
• Provide comprehensive Quality Oversight and expert quality/compliance advice to the Taiwan organization.
• Serve as the Inspection Management Team Lead, leading health authority inspection readiness, inspection management, post-inspection follow-up and cross-functional coordination.
• Drive the implementation of Quality by Design (QbD), risk-based quality management and Continuous Improvement across the local organization.
• Assess risks and emerging trends through the evaluation of Quality Events, internal/external audits, health authority inspection outcomes and quality data.
• Work closely with stakeholders involved in the QMS governance framework, including Quality Management Review (QMR) and Quality Review Board (QRB), to identify areas of risk, process gaps and improvement opportunities.
• Lead the development, implementation and continuous enhancement of the local Quality Management System (QMS) in Taiwan.
• Partner with local functions to define and align priorities in response to evolving business requirements and emerging organizational changes.
• Collaborate with key QA, R&D, Medical, PV and other cross-functional stakeholders to ensure adequate quality support for critical programs and priority initiatives.
• Ensure submission-related and regulatory activities are conducted in accordance with applicable quality and compliance requirements.
• Provide expert guidance to stakeholders on quality and compliance decisions to support sustainable and proactive quality management.
• Provide guidance in the development, execution and effectiveness monitoring of Corrective and Preventive Actions (CAPAs).
• Coordinate and review CAPAs arising from audits, inspections and Quality Events to ensure adequate Root Cause Analysis (RCA), appropriate systemic solutions and acceptable remediation plans.
• Lead formal investigations of significant quality or compliance issues, ensuring timely investigation, remediation and closure.
• Ensure timely escalation to line management and appropriate governance bodies when critical incidents or significant quality/compliance risks are not resolved within an appropriate timeframe.
• Participate in APAC/global quality meetings, inspections, audits and cross-border projects as required, with frequent overseas business travel.