Global ESO Quality Specialist

Global ESO Quality Specialist

Galderma

Uppsala, Barcelona or Alby

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.

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.

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.