APAC Compliance, Commercial & Distribution QA Associate Director

About the role

Abbott is hiring an Associate Director for its APAC Compliance, Commercial & Distribution Quality Assurance function, based in Singapore. The role supports the APAC region's commercial affiliates and sites with quality systems, compliance, commercial quality, distribution quality, audits and regulatory requirements so that compliant, authentic, safe and efficacious products are supplied across the region.

Key responsibilities

• Provide quality systems leadership, tactical and strategic direction, and technical support to commercial affiliates in the APAC region.
• Maintain quality systems for regional supply chain and distribution, including GDP training, internal audit programs, document control, quality manuals, returns management, complaints and discrepancy investigations, and CAPA processes.
• Support affiliates with GDP, including audits, compliance support, event management and exception handling.
• Select and approve logistics and transport service providers and third-party warehouses for APAC supply chain operations.
• Collaborate with Supply Chain, Distribution, Master Data, QA Supplier Management and Global Product Protection teams on counterfeit prevention, regional warehouses, temperature monitoring, transport optimization, serialization, supply chain validation and material listing approvals.
• Develop and manage the APAC Commercial Affiliate Quality Plan and train affiliates on quality goals and standards.
• Manage the First Lot Quality Review program to support local market outsourcing and product launches.
• Implement and manage quality systems covering CAPA, validation, complaint registration, physician sample handling, inspection reporting and tracking, and policy implementation.
• Drive Management Review processes for affiliates and advise senior management on compliance status and risk.
• Oversee quality and compliance across APAC, lead regional GMP training, and support GxP audits for APAC suppliers and affiliates and due diligence audits for new business.

Required profile

• University degree in Life Sciences.
• At least 15 years of combined experience in QA, Operations or Technical functions within a pharmaceutical environment.
• Working experience with commercial and distribution quality is advantageous.
• 2 to 3 years' experience managing complex projects or programs.
• Experience in or with regulatory organizations.

Required skills

• Quality tools such as quality risk management, root cause analysis, benchmarking, gap analysis, Pareto analysis, fish-bone diagrams and process mapping.
• Project management and troubleshooting skills.
• Knowledge of international regulations and industry best practices for quality systems and compliance.
• Ability to identify problems and initiate corrective and preventative actions.
• Continuous improvement methods such as Lean, Six Sigma and Class A.
• Well-developed interpersonal, communication and negotiation skills, and ability to communicate across cultures.