Global ESO Quality Specialist

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 is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day.

Global ESO Quality Specialist (Fixed Term 1-Year)

Primary Location: Uppsala, Sweden

Additional Locations: Alby, France | Barcelona, Spain

We are now looking for a dynamic and experienced QA Specialist to join our External Supplier Organization (ESO) for Sterile Products. This role offers an exciting opportunity to work in a global environment, supporting world-leading brands such as Nemluvio and Sculptra while collaborating closely with external suppliers across the globe.

Position Overview

The role is a Quality Assurance Specialist with 2‑5 years of experience within the medical device, pharmaceutical, or other regulated industries. The ideal candidate will have expertise across QA functions including complaint management, release activities, sterile production, documentation management, and regulatory compliance. This position is within the ESO for Sterile Products and involves close work with external manufacturing partners and suppliers to ensure the highest standards of quality and compliance throughout the product lifecycle.

Key Responsibilities

• Quality Systems: Contribute to the development, implementation, and maintenance of robust quality systems, including complaint management, deviation management, change control, CAPA, and risk management processes. The main responsibility within the QMS area will be complaint management.
• Release Activities: Execute product release activities in compliance with regulatory requirements and company standards. Ensure the timely and accurate release of pharmaceutical products for distribution.
• Sterile Production: Provide QA oversight for sterile manufacturing operations, including aseptic processing, sterilization processes, and environmental monitoring. Ensure adherence to cGMP guidelines, regulatory standards, and applicable ISO requirements.
• Documentation Management: Manage and review quality documentation, including batch records, standard operating procedures, risk assessments, validation protocols, and reports. Ensure documentation complies with regulatory requirements, ISO 13485, MDR, and internal quality standards.
• Regulatory Compliance: Stay up to date with regulatory requirements and industry best practices related to quality assurance. Ensure ongoing compliance with FDA regulations, applicable ISO standards, MDR requirements, and company policies.
• Continuous Improvement: Identify opportunities for process improvement and quality enhancement. Participate in quality improvement initiatives and projects aimed at optimizing quality systems and operational efficiency.

Required Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related field.
• 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 medical device or pharmaceutical manufacturing processes, including the production of sterile biological drugs, terminally sterilized products, and/or aseptically filled products.
• Proficiency in documentation management.
• Familiarity with regulatory requirements, including cGMP, FDA regulations, ISO 13485, MDR, and international guidelines.
• Excellent communication skills.
• Ability to work independently and collaboratively in a dynamic, fast‑paced environment.

Preferred Qualifications

• Pharmacist degree or a Master's degree in Biology, Biotechnology, Biochemistry, Chemistry, Engineering, Microbiology, Life Sciences, or another relevant scientific or engineering discipline.
• Strong problem‑solving and decision‑making skills.

What We Offer in Return

Galderma embraces diversity and inclusion and believes that better outcomes are achieved by reflecting the perspectives of our diverse customer base. The ESO organization includes nearly 60 employees working together in a highly collaborative global environment supporting world‑leading brands such as Nemluvio and Sculptra. You will work in an exciting international setting where professional and personal development are encouraged. Our teams are based in modern offices across Europe, including Uppsala (Sweden), Alby (France), and Barcelona (Spain). Travel will be an integral part of the position.

Who You Are

You are a resilient and quality‑focused professional with a strong sense of ownership and accountability. You thrive in an international and collaborative environment, enjoy building relationships with internal and external stakeholders, and have a passion for ensuring compliance, product quality, and continuous improvement.

Our People Make a Difference

At Galderma, you’ll work with people who are like you—and people who are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive culture create the perfect environment for people to thrive, develop, and excel in what they do.

Join us on this exciting journey and help shape the future of quality within Galderma’s global External Supplier Organization.