Global External Quality Lead - Pharma Compliance & Ops

Amaris Consulting | Part of Mantu; Beerse; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Job summary

Amaris Consulting, part of Mantu, is seeking an External Quality Senior Specialist to support the development and improvement of External Quality processes across the supplier lifecycle in a global pharmaceutical context.

You will collaborate with Quality, Operations, External Manufacturers and Supplier Partners to ensure compliant, efficient procedures and cross-functional alignment in a dynamic environment.

Qualifications

• 7 to 10 years of professional experience, including at least 5 years in the pharmaceutical industry.
• Experience working with external manufacturers, contract suppliers, and supplier quality processes.
• Good knowledge of cGMP, pharmaceutical quality systems, company procedures, and applicable global regulations.
• Broad understanding of Quality functions including Quality Operations, QC, Quality Systems, Validation, Regulatory Affairs, and Operations.

Responsibilities

• Own or support End-to-End External Quality processes and act as a subject matter expert for assigned activities.
• Assess, update, and deploy External Quality procedures covering supplier oversight throughout the lifecycle.
• Manage or support External Quality and Global Quality systems, ensuring compliance with company policies and applicable regulations.
• Monitor processes, identify gaps, and implement improvements based on industry practices, regulatory intelligence, and business needs.
• Ensure External Quality procedures remain consistent with harmonized enterprise processes and support all supplier categories.
• Support process development, system implementation, strategic initiatives, and business improvement projects.
• Build effective relationships with external manufacturers and suppliers, coordinating training, actions, and deliverables within agreed timelines.

Skills

Analytical skills

Problem solving

Excellent communication

Project management

Education

Bachelor's degree or higher in Science/Engineering/Technical Studies

Tools

MS Office

SAP

Job description

Amaris Consulting, part of Mantu, is seeking an External Quality Senior Specialist to support the development and improvement of External Quality processes across the supplier lifecycle in a global pharmaceutical context.

You will collaborate with Quality, Operations, External Manufacturers and Supplier Partners to ensure compliant, efficient procedures and cross-functional alignment in a dynamic environment.