Quality Assurance Specialist

Galderma; Barcelona; Presencial; EUR 40.000 - 70.000; Jornada completa

Descripción de la vacante

Galderma is seeking a dynamic Quality Assurance Specialist with 3–8 years of experience in the medical device or pharmaceutical field. The role focuses on complaint management, release activities, sterile production oversight, and rigorous documentation and regulatory compliance.

You will work within the External Supplier Organization for Sterile Products, collaborating with ESO suppliers to ensure high quality and compliant products globally.

Formación

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related field.
• 5–8 years of experience in quality assurance within medical device, pharmaceutical, or regulated industry.
• Fluency in written and verbal English.
• Strong knowledge of production of sterile products and regulated manufacturing processes.
• Proficiency in documentation management and regulatory requirements (cGMP, FDA, ISO13485, MDR).
• Ability to work independently and collaboratively in a fast-paced environment.

Responsabilidades

• Contribute to quality systems development, complaint management, deviation handling, CAPA, and risk management.
• Execute product release activities in compliance with regulatory requirements.
• Provide QA oversight for sterile manufacturing operations and environmental monitoring.
• Manage and review quality documentation (batch records, SOPs, validation protocols).
• Ensure regulatory compliance with ISO13485, MDR and FDA/regional guidelines.
• Support internal/external audits and supplier due diligence; implement corrective actions.
• Identify opportunities for process improvement and quality enhancement.

Conocimientos

Quality Assurance

Complaint management

Deviation management

CAPA

Risk management

QMS

Release activities

Sterile production

Documentation management

Regulatory compliance

Audits & inspections

Continuous improvement

English fluency

Educación

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

Descripción del empleo

We are currently seeking a dynamic and experienced Quality Assurance (QA) Specialist with 3-8 years of experience in the medical device or pharmaceutical industry. The ideal candidate will have expertise in various QA functions, including complaint management, release activities, sterile production, documentation and regulatory compliance. The position is within the External Supplier Organization (ESO) for Sterile Products and You will work closely with ESO suppliers.

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. Main responsibilities for QMS will be complaint management.

Release Activities: Execute product release activities in compliance with regulatory requirements and company standards. Ensure 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 standards.

Documentation Management: Manage and review quality documentation, including batch records, standard operating procedures (SOPs), risk management, validation protocols, and reports. Ensure documentation complies with regulatory requirements, ISO13485, MDR and internal quality standards.

Regulatory Compliance: Stay abreast of regulatory requirements and industry best practices related to quality assurance. Ensure compliance with FDA regulations, international standards such as applicable ISO standards, and company policies.

Audits and Inspections: Support internal and external audits and regulatory inspections. Support Due Diligence audits for initial qualification of suppliers. Prepare and review audit documentation, respond to audit findings, and implement corrective and preventive actions as necessary.

Continuous Improvement: Identify opportunities for process improvement and quality enhancement. Participate in quality improvement initiatives and projects to optimize quality systems and operational efficiency.

Required Qualifications:

Bachelor's degree in Pharmacy, Chemistry, Biology, or related field.

5-8 years of experience in a quality assurance role within the medical device, pharmaceutical or regulated industry.

Fluency in written and verbal English, any other language is an asset.

Strong operational knowledge of medical device or pharmaceutical manufacturing processes, including production of sterile biological drugs, terminally sterilized and/or aseptically filled products.

Proficiency in documentation management.

Familiarity with regulatory requirements, including cGMP, FDA regulations, ISO13485 & MDR and international guidelines.

Ability to work independently and collaboratively in a dynamic, fast-paced environment.

Preferred Qualifications

Pharmacist or Master's degree in Biology, Biotechnology, Biochemistry, Chemistry, Engineering, Microbiology, Life Science or another relevant scientific or engineering discipline.

Previous experience in reviewing supply agreements and manage quality agreements

Previous experience in leading or participating in regulatory inspections and audits.

Problem-solving, and decision-making skills.

Join us in this dynamic role where resilience, strong management, and team-building skills thrive. Your pivotal role as an experienced QA specialist will contributing significantly to Galderma's growth.

What we offer in return

You will be working for an organisation that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.

In ESO organization nearly 60 employees work together in a global environment on our world leading brands such as Nemluvio and Sculptra.

We are offering you the opportunity to work in an exciting, international environment where both professional and personal development is encouraged.

We are based in modern offices and located in several places in Europe, such as Barcelona, Alby (France) and Uppsala (Sweden). ESO/API suppliers is located across the Globe and travel is part of the position.

Next steps

We welcome your application via our company website CAREERS Galderma and as soon as possible. The selection process is ongoing and the role may be filled prior the last application date.

If your profile is a match, we will invite you for a first virtual conversation with the recruiter

The next step is a virtual conversation with the hiring manager.

The second step is an interview with SRT Director.

The final step is an interview with Head of Global Supply.

Our people make a difference

At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.