QA Specialist Serialization and Automation (12 months)

Overview

We are seeking an experienced Quality Assurance professional to represent Global Quality on two strategic cross-functional programmes within a pharmaceutical manufacturing environment.

The primary focus of the role is a global serialization transformation initiative, where the successful candidate will lead the development and deployment of a harmonised quality framework replacing site-specific serialization procedures. A secondary responsibility involves supporting a new Manufacturing Digital Connect programme by defining quality requirements and governance for emerging automation capabilities.

This position sits within a global quality organisation and requires close collaboration with Quality, Regulatory Affairs, Operations, Digital/IT and commercial stakeholders worldwide.

Responsibilities

• Act as the primary Quality representative for global serialization and automation programmes.
• Provide expert guidance on regulatory compliance, quality systems and GxP expectations.
• Develop and implement a consolidated global serialization SOP framework, replacing local procedures across manufacturing sites.
• Translate global regulatory expectations into practical quality requirements and operational procedures.
• Drive procedural harmonisation and quality alignment across international manufacturing locations.
• Lead risk assessments, change controls and quality impact evaluations.
• Deliver training and competency programmes for Quality and Operations teams.
• Support implementation and adoption of global quality standards.
• Define quality requirements and documentation strategy for Manufacturing Digital Connect initiatives.
• Collaborate with Global Quality, Regulatory Affairs, IT/Digital, Manufacturing Operations and Marketing Authorisation Holders (MAHs).

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Engineering or a related discipline.
• At least 8 years of experience within pharmaceutical or biotech Quality functions.
• Minimum 3 years of experience supporting serialization, track-and-trace or similar global compliance programmes.
• Demonstrated experience writing, implementing and maintaining GxP SOPs.
• Strong understanding of:
  • EU Falsified Medicines Directive (FMD)
  • EMVS/EMVO repository models
  • US DSCSA requirements
  • China traceability expectations and similar national repository frameworks
• Knowledge of serialization technologies and associated quality controls.
• Experience in change control, risk management and quality systems.
• Strong stakeholder management and influencing skills.
• Exposure to manufacturing automation and Data Integrity principles is highly desirable.

Additional Information

• Location: Beerse or other EMEA manufacturing locations
• Working model: Hybrid (3 days onsite / 2 days remote)
• Eligible locations: Belgium, Netherlands, Switzerland, Ireland, United Kingdom and other suitable EMEA locations
• Travel: Approximately 10%
• Contract Length: Through 18 October 2027
• FTE: 80-100%
• Team Size: 4-person global team operating mainly virtually
• BYOD policy applies