QA Specialist

QA Specialist - Serialization & Automation

📍 Belgium / EMEA manufacturing site (hybrid)

About the Role

We are looking for an experienced QA specialist to act as Global Quality Representative on two cross-functional programs within a global quality organization. The main focus is serialization, with a secondary focus on manufacturing automation. You will join a team of 4 that works mostly virtually. This is an execution role, not a management role.

Program 1 (main focus): Serialization

Upgrade and consolidate existing serialization systems and implement regulatory changes and upcoming health authority requirements worldwide. You will author a single global set of serialization procedures that replaces site-level documents, and lead their global alignment and deployment. System/software validation is not in scope.

Program 2 (secondary focus): Manufacturing Digital Connect

A new automation integration layer. You will first assess its quality impact, then define global quality requirements and documentation as the project progresses.

Key Responsibilities

• Act as Global Quality SME and primary QA contact for regulatory and compliance matters on both program teams
• Lead development of one consolidated Global Serialization SOP suite (procedures and work instructions) that supersedes local site documents
• Translate regulatory requirements into site-level quality requirements and procedural controls, and ensure SOP alignment
• Lead training and competency activities on global procedures for QA and operations staff

What You Bring

• 8+ years in Quality within pharmaceutical/biotech manufacturing, including 3+ years responsible for serialization and/or track-and-trace projects at global scale
• A QA background (mandatory), with serialization experience from the quality side
• Hands-on experience writing and implementing global GxP SOPs
• Practical knowledge of the EU Falsified Medicines Directive (EMVS/EMVO), US DSCSA requirements, and China NMPA traceability expectations (or experience with national repository models)
• Technical understanding of serialization; manufacturing automation and data integrity knowledge preferred
• Strong SOP authoring, change control, and risk assessment skills
• Excellent stakeholder management and influencing skills across Global Quality, IT/Digital, Regulatory Affairs, Operations, and commercial/MAH stakeholders
• Bachelor's degree in Pharmacy, Life Sciences, Engineering, or comparable (advanced degree preferred)
• Fluent English, written and spoken

Details

• Start: ASAP
• Duration: 12 months from start date
• Hybrid: 3 days onsite, 2 days remote
• Full-time (100%); 80% (32 hours/week) may be considered
• Travel: approx. 10% to other sites