Quality & Regulatory Director

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 thirdparty logistics providers and local operations.

You will have the opportunity to:

• Define and execute regulatory strategies for new and existing products ensuring timely market authorizations license maintenance and compliance with countryspecific 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 thirdparty logistics providers external warehouses and ongoing compliance through periodic followups and quality audits.
• Act as secondary contact for Pharmacovigilance activities monitoring postmarketing 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.

• 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 thirdparty 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.

• Permanent fulltime position with flexible working arrangements.
• Strategic exposure and close collaboration with global HQ teams.
• A collaborative culture focused on compliance continuous improvement and excellence.

AtGrifols 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

Learn more about Grifols