Job Overview:
The QA Associate Director, APAC ex-India serves as a strategic regional RC&QA solutions partner, providing line management and day-to-day quality leadership across APAC ex-India. The role reports to the designated regional RC&QA leader and executes regional RC&QA strategy and priorities established by regional leadership, translating strategic objectives, business priorities, client expectations, country-specific requirements, and global quality strategy into operational quality solutions, team priorities, stakeholder engagement plans, and measurable outcomes.
The primary focus is execution of regional RC&QA priorities, day-to-day regional quality leadership, stakeholder engagement, client and country support, quality intelligence, risk management, region-specific quality issues, capability building, and continuous improvement. Global AIM retains ownership of audit and inspection execution processes, logistics, and administrative workflow, while the Associate Director provides regional expertise, stakeholder engagement, country support, SME leadership, and coordination or execution of selected activities based on risk, business need, language requirements, and resource availability.
The role acts as a senior regional technical SME and a constructive interface between operations, clients, country teams, and global quality functions. It brings forward regional intelligence and recommendations while supporting sustainable team delivery. Professional fluency in English and Mandarin Chinese is required to provide effective support for regional stakeholders and Chinese-language activities.
Summary of Responsibilities:
- Execute regional RC&QA strategy and priorities established by regional leadership, providing day-to-day quality leadership, line management, and practical, independent, risk-based regulatory and compliance advice across APAC ex-India. Translate business priorities, quality risks, client expectations, country requirements, local operating practices, and cultural considerations into clear team objectives, resource decisions, stakeholder engagement plans, and measurable outcomes.
- Serve as the primary RC&QA subject matter expert for APAC ex-India, providing interpretation of regulations, quality strategy, inspection intelligence, quality issue governance, escalation support, and consultation on complex compliance matters.
- Develop and maintain strategic partnerships with country leadership, regional operations leaders, and client delivery teams to identify emerging risks, incorporate quality considerations into business decisions, and provide coordinated support to country and client-facing teams.
- Support regional business development and growth by contributing quality strategy, regulatory insight, inspection intelligence, risk assessments, quality narratives, and technical expertise for proposals, due diligence, bid defenses, sponsor qualification activities, and client discussions.
- Represent APAC ex-India RC&QA in regional and global quality forums, sponsor governance meetings, quality reviews, inspection-readiness activities, client engagements, and business decision-making, ensuring regional risks, country and client considerations, and recommended actions are visible to appropriate stakeholders.
- Lead regional quality intelligence and coordinate Quality Management Review inputs by integrating meaningful metrics, audit outcomes, inspection intelligence, quality trends, recurring issues, CAPA themes, stakeholder feedback, risk assessments, and inspection-readiness updates into actionable management insights and improvement priorities.
- Provide RC&QA leadership for significant regional quality events, client escalations, protocol compliance concerns, regulatory reportability assessments, inspection findings, and issues with potential participant safety, trial integrity, or data integrity implications. Facilitate appropriate investigation, impact assessment, root-cause analysis, CAPA, escalation, and resolution in partnership with accountable business and functional owners.
- Provide regional coordination, expertise, oversight, or execution support for selected vendor, for-cause, study, project, rescue-study, or process audits through Global AIM governance, based on risk, business need, language requirements, direction, and resource availability.
- Provide regional technical expertise and stakeholder coordination for sponsor audits, regulatory inspections, inspection readiness, and for-cause matters, mobilizing relevant country and functional SMEs and ensuring regional input is accurate, timely, and aligned with applicable global AIM processes.
- Drive regional improvement initiatives that strengthen quality culture, Quality by Design, proactive issue prevention, fit-for-purpose quality management, stakeholder partnership, and scalable delivery.
- Interpret applicable regulations and standards and provide regional input to policies, procedures, guidance, and implementation approaches to ensure they remain practical, compliant, and responsive to APAC ex-India operating environments.
- Provide direct line management, coaching, workload prioritization, performance management, development planning, succession support, backup coverage, and capability building for regional QA personnel, and deploy appropriately trained resources and functional SMEs to meet regional priorities and language needs.
- Communicate significant risks and escalation matters promptly, distill complex information into clear executive messages, negotiate constructive outcomes, and maintain transparent progress updates through resolution.
- Fulfil RC&QA management responsibilities defined in applicable controlled documents, act as a delegate for RC&QA leadership when assigned, represent Fortrea externally as an industry SME where appropriate, and contribute to regional and global quality objectives and other assigned duties.
Qualifications (Minimum Required):
- A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience).
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable.
- Experience may be substituted for education with company requirements
Experience (Minimum Required):
- At least 14 years of experience in a regulatory or GxP environment, with substantial experience in quality assurance and regional quality leadership.
- Strong knowledge of industry quality systems, regulations, and standards, with the ability to translate requirements into practical, risk-based advice and solutions.
- Experience supporting sponsor audits, regulatory inspections, quality issue management, investigations, CAPA, quality intelligence, and continuous improvement, including activities involving APAC regulatory authorities such as NMPA, PMDA, TGA, MFDS, HSA, and TFDA.
- Demonstrated understanding of APAC regulatory expectations, operating environments, client needs, cultural considerations, and language-related risks.
- Experience directly managing or functionally leading geographically dispersed quality professionals and multidisciplinary teams, including mobilizing functional SMEs to address complex quality, audit, inspection, and improvement needs.
- Ability to identify systemic issues, assess regulatory and business risk, develop sustainable corrective and preventive action strategies, and present quality metrics, trends, risks, and recommendations to senior stakeholders.
- Strong client partnership, business development, communication, influence, and negotiation skills, with the ability to distill complex information into clear executive messages.
- Experience with electronic quality, audit, or data management systems is preferred.
- Professional fluency in English and Mandarin Chinese is required, including the ability to communicate with regional stakeholders and review, interpret, and discuss Chinese-language information. Additional APAC language capability is preferred.
Physical Demands/Work Environment:
- Some overtime and weekend work may be required.
- Travel is required based on client, business, regional quality, audit, and inspection needs.
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