Global QA Lead: Serialization & Automation

Pauwels Consulting; Beerse; On-site; EUR 90,000 - 120,000; Full time

Job summary

Pauwels Consulting is seeking an experienced QA Specialist for a global pharmaceutical client. You will serve as the Global Quality SME for serialization and automation programs across the organization.

The role focuses on consolidating serialization systems, defining quality requirements for a new automation layer, and aligning procedures across manufacturing sites. English fluency and knowledge of EU FMD, US DSCSA, and China NMPA are essential.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, or Engineering.
• 8+ years of quality experience in the pharmaceutical industry with 3+ years focused on global serialization or track-and-trace projects.
• Strong skills in SOP authoring, change control, and risk assessment.
• Knowledge of regulatory requirements including EU Falsified Medicines Directive, US DSCSA, and China NMPA.
• Technical understanding of manufacturing automation and Data Integrity.
• Excellent stakeholder management and influencing skills within a global, virtual team environment.
• Fluent in English.

Responsibilities

• Serve as the primary Global Quality SME for serialization and automation programs across the organization.
• Lead the development and consolidation of a single global SOP suite for serialization to replace existing site-level documentation.
• Translate international regulatory requirements into site-level quality controls and procedural standards.
• Ensure global alignment of procedures and lead training activities for quality and operations staff.
• Define global quality requirements and documentation for new automation integration layers as projects progress.
• Manage stakeholders across Global Quality, IT, Regulatory Affairs, and Operations to ensure program compliance.

Skills

Serialization

Track-and-trace

SOP authoring

Change control

Risk assessment

Stakeholder management

English

Education

Bachelor's degree in Pharmacy

Bachelor's degree in Life Sciences

Bachelor's degree in Engineering

Job description

Pauwels Consulting is seeking an experienced QA Specialist for a global pharmaceutical client. You will serve as the Global Quality SME for serialization and automation programs across the organization.

The role focuses on consolidating serialization systems, defining quality requirements for a new automation layer, and aligning procedures across manufacturing sites. English fluency and knowledge of EU FMD, US DSCSA, and China NMPA are essential.