Global QA Specialist: Sterile Products & Compliance

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

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.