Global ESO Quality Specialist

Q-Med Uppsala; Uppsala kommun; On-site; SEK 65,000 - 90,000; Full time

Benefits offered by this job

International setting

European offices

Travel opportunities

Diversity culture

Job summary

Galderma is seeking a QA Specialist to join our External Supplier Organization for Sterile Products. The role focuses on quality systems, regulatory compliance, and continual process improvement in a global setting.

You will work with external suppliers worldwide, oversee sterile production, release activities, documentation, and risk management, ensuring cGMP, ISO 13485 and MDR standards are met.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, or Biology.
• 2–5 years QA experience in regulated industry.
• Fluency in written and spoken English; additional languages are an advantage.
• Strong knowledge of quality systems and regulatory requirements.

Responsibilities

• Quality Systems – develop, implement, and maintain quality systems including complaint, deviation, change control, CAPA, and risk management; focus on complaint management.
• Release Activities – perform product release in compliance with regulatory requirements.
• Sterile Production – QA oversight for aseptic processing, sterilization, and environmental monitoring.
• Documentation Management – review batch records, SOPs, risk assessments, validation protocols, and reports.
• Regulatory Compliance – stay up to date with FDA, ISO 13485, MDR, MDR and other regulations.
• Continuous Improvement – identify opportunities for process and quality improvements.

Skills

Quality Assurance

Regulatory compliance

Documentation

English language

Education

Bachelor’s degree in Pharmacy, Chemistry, or Biology

Job description

Position Overview

Galderma is seeking a dynamic and experienced QA Specialist to join our External Supplier Organization (ESO) for Sterile Products. The 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.

Location: Uppsala, Sweden (primary), with additional locations in Alby, France and Barcelona, Spain.

The specialist will play a critical role in ensuring product quality, regulatory compliance, and the continuous improvement of our quality systems and processes.

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.

Benefits

• Opportunity to work in an exciting international setting where professional and personal development are encouraged.
• Modern offices across Europe in Uppsala (Sweden), Alby (France), and Barcelona (Spain).
• Travel integral to the position, providing experience with suppliers worldwide.
• Diverse and inclusive culture that values all team members and fosters collaboration.