Quality & Regulatory Director
Singapore, SG
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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. |
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At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment where everyone can reach their full potential.
We are currently looking for a Quality & Regulatory Affairs Director to ensure the effective management of Quality, Regulatory Affairs and Pharmacovigilance activities across the Asia Pacific region, covering Biopharma, Diagnostics and Healthcare Solutions.
The Quality & Regulatory Affairs Director is a key member of the regional organization and acts as the Responsible Person as defined by local regulations. This role is responsible for maintaining the Quality Management System in compliance with company SOPs, local regulatory requirements, and international GDP/GMP standards, while also leading and developing the local QRA team.
You will act as the technical reference in the country, representing Grifols before health authorities, collaborating closely with HQ, and ensuring compliance across third‑party logistics providers and local operations.
What you will do
You will have the opportunity to:
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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.
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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.
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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.
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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.
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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.
Who you are
- 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, escalate appropriately, and work autonomously. Proven people management and coaching capabilities.
- Fluent English is required.
- Willingness to travel occasionally.
What we offer
- Permanent full‑time position with flexible working arrangements.
- Strategic exposure and close collaboration with global HQ teams.
- A collaborative culture focused on compliance, continuous improvement and excellence.
At Grifols, we are committed to developing our people and empowering careers.
If you are interested in joining Grifols and meet the qualifications, please apply
Location: APAC : Singapore : Singapore:Singapore