Global QA Specialist — Sterile & External Suppliers

Galderma Nordic AB; Uppsala kommun; On-site; SEK 520,000 - 700,000; Full time

Job summary

Galderma Nordic AB is seeking a Global ESO Quality Specialist (Fixed Term 1-Year) based in Uppsala, Sweden, with 2–5 years of QA experience in regulated environments. The role supports the External Supplier Organization for Sterile Products and collaborates with external manufacturers globally.

You will contribute to quality systems, release activities, sterile production oversight, and regulatory compliance to ensure alignment with cGMP, ISO 13485, and MDR across the product lifecycle.

Qualifications

• 2–5 years of experience in a Quality Assurance role within the medical device, pharmaceutical, or other regulated industry.
• Fluency in written and spoken English; additional languages are considered an advantage.
• Strong operational knowledge of sterile manufacturing processes, including aseptic processing and sterilization.
• Proficiency in documentation management and regulatory requirements (cGMP, FDA, ISO 13485, MDR).
• Excellent communication skills and ability to work independently and in a team.
• Familiarity with regulatory requirements and international guidelines.
• Pharmacist degree or related advanced degree is preferred.

Responsibilities

• Quality Systems: Develop, implement, and maintain robust quality systems, focusing on complaint management, deviation management, change control, CAPA, and risk management.
• Release Activities: Execute product release activities in compliance with regulatory requirements and company standards.
• Sterile Production: Provide QA oversight for sterile manufacturing operations, including aseptic processing and environmental monitoring.
• Documentation Management: Manage batch records, SOPs, risk assessments, validation protocols, and quality reports.
• Regulatory Compliance: Stay up to date with regulatory requirements (FDA, ISO 13485, MDR) and internal quality standards.
• Continuous Improvement: Identify opportunities for process improvement and drive quality enhancement.

Skills

Quality Assurance

Regulatory Compliance

Documentation management

Release activities

Sterile production

cGMP

CAPA

Risk management

Communication

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, or related field

Pharmacist degree or Master’s in Biology/Biotech/Chemistry/Engineering/Life Sciences

Job description

Galderma Nordic AB is seeking a Global ESO Quality Specialist (Fixed Term 1-Year) based in Uppsala, Sweden, with 2–5 years of QA experience in regulated environments. The role supports the External Supplier Organization for Sterile Products and collaborates with external manufacturers globally.

You will contribute to quality systems, release activities, sterile production oversight, and regulatory compliance to ensure alignment with cGMP, ISO 13485, and MDR across the product lifecycle.