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
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