QA Specialist Serialization and Automation (F/H/X)

Location: Beerse, Belgium; remote work is available.

Company

hirify.global is an independent technology consulting firm delivering technology, life sciences, engineering, and digital solutions to businesses through an international team.

What you will do

• Act as the Global Quality SME and primary QA contact for international serialization and Manufacturing Digital Connect programs.
• Lead the creation and implementation of a consolidated global serialization SOP suite replacing local procedures.
• Translate EU FMD, EMVS/EMVO, US DSCSA, China NMPA, and other regulatory requirements into global procedures and site controls.
• Assess the quality impact of the automation integration layer and define its GxP and data integrity requirements.
• Lead SOP reviews, change controls, risk assessments, deviation follow-up, and quality action plans.
• Coordinate training, competency activities, documentation, governance, and project updates with Global Quality, IT, Regulatory Affairs, Manufacturing, Operations, commercial, and site stakeholders.

Requirements

• Bachelor’s or master’s degree in Pharmacy, Life Sciences, Engineering, or a comparable field.
• At least 8 years of experience in Quality within pharmaceutical or biotech manufacturing.
• At least 3 years of experience with global serialization, track-and-trace, or similar compliance programs.
• Hands-on experience writing and implementing global GxP SOPs and work instructions.
• Good knowledge of cGMP, data integrity, quality risk management, change control, serialization systems, pharmaceutical regulations, and national traceability models.
• Fluent English required; strong stakeholder management and communication skills.

Nice to have

• Dutch language skills.

Culture & Benefits

• Projects typically last around 18 months and involve major international clients.
• Regular project check-ins, manager support, and monthly HR conversations.
• Career development, functional mobility, and international mobility across more than 60 countries.
• Access to more than 250 training modules and fully funded Microsoft certifications.
• Health insurance, remote work, meal vouchers, a time savings account, and a referral bonus.

Hiring process

• Brief virtual or phone conversation.
• Approximately three interviews with the line manager and other relevant stakeholders.
• Potential case study, technical assessment, role play, or problem-solving exercise depending on the position.