Senior Quality & Process Leader, External Operations

MindCapture BV; Belgique; Remote; EUR 85,000 - 120,000; Full time

Benefits offered by this job

Meal vouchers

Eco vouchers

Health insurance

Group insurance

Net expense allowance

Company car with charging or fuel card

Training and career development

Job summary

MindCapture BV is seeking an External Quality Senior Specialist, Process and Operations to own and support end to end external quality processes. You will contribute to quality management system development and deploy regulatory intelligence for client programs on site.

The role emphasizes process ownership, QMS development, supplier quality, GMP knowledge, and continuous improvement across global quality systems, with collaboration across teams and external manufacturers.

Qualifications

• Degree in science, engineering or another relevant technical discipline.
• At least five years of experience within the pharmaceutical industry.
• Working knowledge of external manufacturers and supplier partners.
• Strong knowledge of GMP requirements, policies and procedures.
• Experience across quality operations, quality control, quality systems, validation or regulatory
• Understanding of global pharmaceutical regulations.
• Excellent written and verbal communication with internal and external stakeholders.
• Ability to identify gaps, root causes and develop solutions.
• Proficiency with common office and ERP systems.
• Ability to work independently and meet tight deadlines.

Responsibilities

• Own processes and support end to end external quality process owners.
• Support development and deployment of quality management systems.
• Assess and update procedures governing quality oversight of external suppliers.
• Lead and support external and global quality systems.
• Monitor and improve quality processes using industry best practices.
• Ensure lean and agile quality processes across supplier lifecycles.
• Apply regulatory intelligence to maintain quality and compliance requirements.
• Support business processes and improvement projects.

Skills

GMP knowledge

Quality operations

Quality systems

Regulatory knowledge

Analytical skills

Communication

Digital proficiency

Independence

Supplier quality

Process ownership

Education

Degree in science, engineering or relevant technical discipline

Tools

ERP systems

Job description

MindCapture BV is seeking an External Quality Senior Specialist, Process and Operations to own and support end to end external quality processes. You will contribute to quality management system development and deploy regulatory intelligence for client programs on site.

The role emphasizes process ownership, QMS development, supplier quality, GMP knowledge, and continuous improvement across global quality systems, with collaboration across teams and external manufacturers.