APAC Quality & Regulatory Director - Strategy & Compliance

Grifols, S.A; Singapore; On-site; SGD 240,000 - 360,000; Full time

Benefits offered by this job

Flexible schedule

Global exposure

Collaborative culture

Job summary

Grifols, a global healthcare company, is seeking a Quality & Regulatory Affairs Director to oversee QA, regulatory affairs and pharmacovigilance across Asia Pacific, including Biopharma, Diagnostics and Healthcare Solutions.

The role acts as Responsible Person, maintains the Quality Management System in line with GDP/GMP, leads the QRA team, coordinates with HQ and health authorities, and ensures compliant operations across partners.

Qualifications

• Degree in Pharmacy.
• At least 5 years of experience in Quality and Regulatory Affairs within pharmaceuticals, medical devices or IVDs.
• Solid knowledge of GMP, GDP, ISO standards and local regulatory frameworks.
• Experience working with third‑party logistics providers and overseeing warehouse compliance.
• Strong stakeholder management skills, with the ability to communicate effectively with HQ, local teams, partners and health authorities.
• Highly organized, proactive, and able to prioritize, elevate appropriately, and work autonomously. Proven people management and coaching capabilities.
• Fluent English is required.
• Willingness to travel occasionally.

Responsibilities

• Define and execute regulatory strategies for new and existing products, ensuring timely market authorizations, license maintenance, and compliance with country‑specific requirements across Asia Pacific markets.
• Manage and maintain the Quality Management System, including documentation control, SOP creation and revision, quality metrics monitoring, and compliance with GMP, GDP and ISO standards.
• Lead lot release and batch inspection processes, overseeing qualified third‑party logistics providers, external warehouses, and ongoing compliance through periodic follow‑ups and quality audits.
• Act as secondary contact for Pharmacovigilance activities, monitoring post‑marketing surveillance, adverse events, product complaints, recalls, and field safety corrective actions, while supporting investigations, deviations and CAPAs.
• Collaborate closely with HQ, local teams and external partners, maintaining regulatory documentation and databases, supporting tender documentation, and contributing to the standardization and continuous improvement of regulatory and quality practices across the region.

Job description

Grifols, a global healthcare company, is seeking a Quality & Regulatory Affairs Director to oversee QA, regulatory affairs and pharmacovigilance across Asia Pacific, including Biopharma, Diagnostics and Healthcare Solutions.

The role acts as Responsible Person, maintains the Quality Management System in line with GDP/GMP, leads the QRA team, coordinates with HQ and health authorities, and ensures compliant operations across partners.