Global ESO Quality Specialist

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. Since our foundation in 1981 we have dedicated our focus and passion to the human bodys largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives we are advancing dermatology for every skin story.

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. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company we embrace diversity and respect the dignity privacy and personal rights of every employee.

At Galderma we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled direct impact.

Global ESO Quality Specialist (Fixed Term 1-Year)

Primary Location: Uppsala Sweden

Additional Locations: Alby France Barcelona Spain

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 Nemluvio 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 25 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

Bachelors degree in Pharmacy Chemistry Biology or a related field.

25 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 Masters 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 Galdermas continued growth and success.

Our People Make a Difference

At Galderma youll work with people who are like youand 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 Galdermas global External Supplier Organization.