Global QA Specialist — Serialization & Automation (Remote)

MANTU GROUP SA; Belgique; Hybrid; EUR 90,000 - 115,000; Full time

Benefits offered by this job

Projects with substance

Career progression

Learning and technology

Social and environmental commitments

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Job summary

Amaris Consulting, part of the Mantu group, seeks a Global QA Specialist for serialization and automation initiatives in pharmaceutical manufacturing. You will act as the Quality representative for two international programs, driving global SOPs and ensuring regulatory alignment.

You will collaborate with Global Quality, IT, Regulatory Affairs, Manufacturing, Operations and external stakeholders, translate regulatory requirements into global procedures, and support project governance.

Qualifications

• Bachelor's or master's degree in a relevant field.
• Minimum 8 years ofQuality experience in pharma/biotech manufacturing.
• At least 3 years in serialization, track-and-trace, or similar programs.

Responsibilities

• Act as Global QA contact for serialization and Manufacturing Digital Connect programs.
• Lead global serialization SOP suite development replacing local procedures.
• Translate regulatory requirements into global procedures and site controls.
• Assess quality impact of automation layer and define GxP/data integrity needs.
• Coordinate training and competency activities for QA and Operations.
• Maintain inspection-ready documentation and report project updates.

Skills

Fluent English

Stakeholder management

Quality management

Regulatory compliance

Education

Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Engineering

Job description

Amaris Consulting, part of the Mantu group, seeks a Global QA Specialist for serialization and automation initiatives in pharmaceutical manufacturing. You will act as the Quality representative for two international programs, driving global SOPs and ensuring regulatory alignment.

You will collaborate with Global Quality, IT, Regulatory Affairs, Manufacturing, Operations and external stakeholders, translate regulatory requirements into global procedures, and support project governance.