QA Specialist Serialization & Automation

Our client, a leading global pharmaceutical organization, is seeking an experienced QA Specialist to serve as a global Quality Representative. The role focuses on consolidating international serialization systems and defining quality requirements for a new automation integration layer across various manufacturing sites.

• 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.

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

Nice to Haves

• Possession of an advanced degree in a relevant scientific or technical discipline.
• Practical experience with national repository models for medicinal traceability.

• Enjoy a competitive salary package with extra perks that recognize your talent.
• Advance your career with a clear growth path, coaching, and mentoring to support you.
• Thrive in a dynamic and supportive environment where you can truly make an impact.
• Work when and where you perform best, ensuring an optimal work-life balance.
• Choose a flexible transport solution, from a company car to a public transport subscription.
• Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
• Grow your skills with external courses and our in-house Pauwels Academy.
• Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
• Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.