Senior Quality Assurance Manager, Regional

About the CompanyA growing international pharmaceutical company focused on bringing innovative medicines to patients with unmet medical needs and improving access to high-quality treatments across emerging markets.The company is expanding its regional presence in Asia, with an innovative portfolio spanning oncology, immunology and metabolic diseases, including pipelines originating from China.About the RoleThe Senior Manager, Quality Assurance will lead regional Quality Assurance activities across Southeast Asia, ensuring compliance with applicable GMP, GDP, cold-chain, ambient temperature and product quality requirements across regional supply chains and distribution networks.This is a high-ownership, build-from-the-ground-up role. As the initial Quality lead in the region, you will establish and maintain the regional Quality Management System (QMS), oversee external manufacturing and commercial partners, and build the quality governance framework supporting the company's regional growth.The role also carries a strategic hybrid mandate beyond traditional QA responsibilities. You will establish the foundational Pharmacovigilance (PV) framework, including safety reporting processes, adverse event intake and escalation pathways, partner safety obligations and vendor oversight until a dedicated PV function is established.You will work closely with the VP, Strategy & Market Access and the broader leadership team, as well as cross-functional stakeholders across Regulatory Affairs, Medical Affairs, Business Development and Commercial functions.Key ResponsibilitiesQuality Management System & ComplianceEstablish, implement and maintain the regional Quality Management System (QMS).Develop and maintain SOPs, document control and training systems.Lead deviation, CAPA, change control and quality risk management processes.Establish appropriate quality governance and management review processes.Ensure quality standards are maintained throughout the product lifecycle.Regional Quality & Supply Chain OversightProvide quality oversight of licensors, external manufacturers, regional warehouses, 3PL providers, distributors and other external partners.Establish and maintain Quality Agreements with relevant external parties.Lead partner qualification, performance monitoring and quality audits.Ensure appropriate GMP/GDP interfaces, escalation mechanisms and compliance across the regional supply chain.Regulatory & Inspection ReadinessSupport regulatory submissions, Health Authority queries and regional regulatory activities.Provide QA support for GMP compliance, product quality matters and inspection readiness.Support GDP audits and inspections across Southeast Asian markets.Ensure compliance with applicable local quality and distribution requirements.Product Quality & ComplaintsLead regional oversight of product complaints, quality defects and market recalls.Oversee investigations, escalation, documentation and CAPA activities.Coordinate product quality matters with licensors, distributors, Regulatory Affairs, Medical Affairs and other relevant stakeholders.Pharmacovigilance GovernanceEstablish and oversee the initial regional PV operating framework.Develop safety reporting processes, PV SOPs and escalation pathways.Establish safety agreements and define PV responsibilities for external partners.Provide oversight of licensors, distributors, PV vendors and other service providers.Coordinate adverse event intake and reporting processes until a dedicated PV function is established.Cross-Functional ResponsibilitiesEnsure appropriate QA and initial PV requirements are incorporated into Named Patient Programmes (NPP), early access, special access and other pre-commercial activities.Develop and deliver QA/PV-related training for internal teams and external partners.Work closely with Regulatory Affairs, Medical Affairs, Business Development and Market Access teams to maintain appropriate quality and patient-safety standards.Provide quality input into pre-launch and other strategic product activities.What You Will BringExperienceBachelor’s degree or above in Pharmacy, Pharmaceutical Sciences, Life Sciences or a related discipline.8+ years of experience in pharmaceutical or biotech Quality Assurance, preferably within biologics, innovative medicines or specialty pharmaceuticals.Strong knowledge and practical experience across GMP, GDP and Quality Management Systems.Proven experience in QMS design and implementation, SOPs, deviations/CAPA, change control, quality risk management, product complaints and recalls.Experience developing and managing Quality Agreements and overseeing external partners.Regional experience across Southeast Asia / APAC within pharmaceutical manufacturing, distribution or commercial environments.Familiarity with Singapore HSA and regional GDP requirements is an advantage.Working knowledge of Pharmacovigilance and safety reporting requirements.Experience working with licensors, external manufacturers, distributors, 3PLs, PV vendors or other third-party service providers.Experience with NPP, early access, special access or pre-launch programmes is an advantage.Skills & CapabilitiesStrong cross-functional leadership and stakeholder management skills.Excellent professional judgment and the ability to work independently.Comfortable building processes and structure in an evolving environment.Agile, adaptable and resilient, with the ability to operate effectively in a growing biopharmaceutical organization.Professional proficiency in Mandarin is a strong advantage, particularly for engagement with China-based manufacturing partners.Why This OpportunityBuild from the ground up: Establish the regional QMS and initial PV framework from day one.Regional ownership: Lead QA across Southeast Asia, working with manufacturers, licensors, distributors and 3PL partners.Senior leadership exposure: Work directly with the VP and broader leadership team in a flat, agile environment.Innovative portfolio: Gain exposure to oncology, immunology and metabolic disease pipelines, including innovative assets from China.Broader career exposure: Expand beyond traditional QA into PV, NPP, pre-launch, in-licensing and international commercialization.