Global ESO Quality Specialist

Q-Med Aktiebolag; Uppsala kommun; On-site; SEK 480,000 - 600,000; Full time

Job summary

Galderma seeks a Global ESO Quality Specialist (Fixed Term 1-Year) in Uppsala to lead QA activities across external suppliers, ensuring cGMP compliance and ISO 13485 alignment. The role requires 2–5 years in QA within regulated industries and a solid background in sterile production.

You will manage complaint handling, release activities, deviation/CAPA processes, and documentation, coordinating with global manufacturers. English fluency is essential; travel is expected.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related field.
• 2–5 years of QA experience in medical devices, pharmaceuticals, or other regulated industry.
• Fluency in written and spoken English; additional languages are advantageous.
• Strong knowledge of sterile production, cGMP, FDA regulations, ISO 13485, MDR.
• Proficiency in documentation management.
• Ability to work independently and collaboratively in a fast-paced environment.

Responsibilities

• Develop, implement, and maintain robust quality systems (QMS) with emphasis on complaint management and CAPA.
• Execute product release activities in compliance with regulatory requirements.
• Provide QA oversight for sterile manufacturing and aseptic processing.
• Manage and review quality documentation (batch records, SOPs, risk assessments).
• Stay updated on regulatory requirements (FDA, ISO 13485, MDR) and ensure ongoing compliance.

Skills

Fluency in English

Independent work

Education

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

Master’s degree in Life Sciences or related discipline

Job description

Global ESO Quality Specialist (Fixed Term 1-Year)

Primary Location: Uppsala, Sweden

At Galderma, we advance dermatology for every skin story. 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 Nemluvo and Sculptra while collaborating closely with external suppliers across the globe. As part of ESO, you will play a critical role in ensuring product quality, regulatory compliance, and the continuous improvement of our quality systems and processes.

Position Overview

We are seeking 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 various QA functions, including complaint management, release activities, sterile production, documentation management, and regulatory compliance.

The position is within the External Supplier Organization (ESO) for Sterile Products, and you will work closely 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 Quality Management System (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 (SOPs), 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.

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.
• · 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

You will be working for an organization that embraces diversity and inclusion and believes that better outcomes are achieved by reflecting the perspectives of our diverse customer base.

Within the ESO organization, nearly 60 employees work together in a highly collaborative global environment supporting world-leading brands such as Nemluvio and Sculptra.

We offer the opportunity to work in an exciting international setting where both professional and personal development are encouraged. Our teams are based in modern offices across Europe, including Uppsala (Sweden), Alby (France), and Barcelona (Spain).

As you will be working closely with suppliers located across the globe, travel is 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.

Your expertise and engagement will contribute significantly to Galderma's continued growth and success.

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.

Krav

• SQE Supplier Quality Engineer - 2-4 års erfarenhet

75228 UPPSALA

Uppsala Kommun