Group Senior Expert - QA IT

Become part of a vital chain and contribute to our common goal of making people’s lives better. Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced from human plasma and human cell lines. We are a privately-owned company, where the warmth of family meets the scale of a global organisation.

Octapharma AB is located in the northwestern area of Kungsholmen, Stockholm, and employees around 1,100 people.

In the role as Group Senior Expert QA IT, you will work with Corporate quality assurance and ensure compliance and Quality oversight of computerized systems, including reviewing and approving GMP documentation in accordance with applicable requirements for patient safety and quality – both in daily operations and in projects.

You will also be responsible for maintaining and further developing the company’s quality management system in relation to IT systems, as well as ensuring that applicable quality requirements and procedures are communicated and adhered to within the organisation. You will collaborate closely with functions such as IT, Production, Engineering, QC, and Supply Chain.

Join us in shaping our vision to provide new health solutions advancing human life.

Your main tasks and responsibilities

• Act as QA representative in corporate IT projects and routine IT system oversight, including releases, updates, corrections, improvements, and reviews
• Perform reviews and approvals of corporate qualifications and validations related to equipment and IT systems
• Act as subject matter expert (SME) within QA, supporting qualification and validation activities across equipment and IT systems
• Review and approve corporate procedures related to qualification/validation, IT, and IT applications
• Support and ensure compliance with QA requirements in IT-related processes and system lifecycle management
• Responsible for qualification of IT system service providers including audits

Your expertise and ideal skill set

• University or College degree in e.g. Chemistry, Chemical Engineering, Pharmacy, or similar
• At least 5 years of experience working with quality-related tasks within the pharmaceutical industry
• Deep knowledge of current GMP regulations, 21 CFR part 11 and EU annex 11
• Documented training in computerized system validation within the pharmaceutical industry
• Solid understanding of quality system standards relevant for qualification/validation
• Very good English skills, both written and spoken
• Fluency in Swedish and English

Your department - where you make an impact

• Overall responsibility for quality assurance of our medicines
• Regulatory compliance and quality assurance for comprehensive systems
• Manufacture of biological medicines entails extra high-quality requirements
• Works together with other functions related to everything from the blood plasma we use as raw material to the final release of the finished product to our patients
• The Corporate Quality Assurance consists of 16 people and you report to the head of the department

Thrive with us

• You save lives – We manufacture life‑saving medicines every day.
• Benefits – Bonus program, benefits portal, on‑site naprapath and more.
• Family‑oriented culture – Long‑term focus on people and relationships.
• Bistro Bryggeriet – Home‑cooked meals, in‑house bakery and café.
• Competence development – Courses, trainee programs and digital learning solutions.

It´s in our blood

We live diversity and stand for equal opportunities as an employer! We therefore look forward to receiving your application - regardless of age, gender, origin, sexual orientation, and religion.

The Recruitment Process

• Our recruitment process includes occupational psychological assessments, interviews, and reference checks. You can read more about our recruitment process here.
• For the final candidate, alcohol and drug testing will be carried out by our occupational health provider.

Apply Today!

Please apply in English. If you have questions about the position, contact Josefina Kihlström (Responsible recruiter) at [email protected]. The application deadline Is 2026-07-05, but the position may be filled before then.

Want to find out more about us?

Visit our website Octapharma Career and follow us daily on LinkedIn.

About Octapharma

Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. We employ more than 11,000 people worldwide to support the treatment of patients in 120 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. With seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany, and Sweden, Octapharma also operates over 195 plasma donation centres across Europe and the US. With four decades of experience, we are committed to advancing patient care worldwide.