Global Quality & Regulatory Affairs Director

Unimed Maritime Solutions; Rotterdam; Vor Ort; EUR 150.000 - 190.000; Vollzeit

Zusammenfassung

Unimed Maritime Solutions is seeking a senior leader to steer global compliance, regulatory and quality programs. You will ensure GDP, GMP and ISO standards are embedded across operations, with governance of AI-enabled systems and data integrity.

Reporting to the CEO and serving on the Senior Management Team, you will lead a cross-functional quality and regulatory affairs function, manage inspections, CAPAs, audits and supplier qualification, and travel 20–30% to Unimed sites and partners.

Qualifikationen

• Bachelor's degree in Pharmacy, Health Sciences or a related scientific discipline.
• 8+ years of senior-level compliance, regulatory and quality experience in regulated industries.
• Strong knowledge of GDP, GMP, ISO standards and Quality Management Systems.
• Experience with sanctions screening, due diligence and multi-jurisdiction licensing.
• Fluent English written and spoken; travel 20–30%.

Aufgaben

• Lead regulatory compliance, maintain registrations and licenses with authorities.
• Own and improve the global Quality Management System across GDP, ISO standards.
• Develop and resource the Quality and Regulatory Affairs team across regions.
• Oversee CAPAs, deviations, changes, root-cause investigations and remediation.
• Oversee sanctions screening and due diligence for customers and vendors.
• Lead audits and inspections and drive governance of AI-enabled systems.

Kenntnisse

English proficiency

Regulatory leadership

Quality management

CAPA management

Data governance

Audits & inspections

Risk analysis

Cross-functional leadership

Ausbildung

Bachelor's degree (Pharmacy/Health Sciences)

Tools

GAMP 5

Jobbeschreibung

Unimed Maritime Solutions is seeking a senior leader to steer global compliance, regulatory and quality programs. You will ensure GDP, GMP and ISO standards are embedded across operations, with governance of AI-enabled systems and data integrity.

Reporting to the CEO and serving on the Senior Management Team, you will lead a cross-functional quality and regulatory affairs function, manage inspections, CAPAs, audits and supplier qualification, and travel 20–30% to Unimed sites and partners.