Quality Systems Manager

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information:

Olink part of Thermo Fisher Scientific is dedicated to advancing the understanding of human disease through proteomics. Olink panels provide innovative high-quality solutions for human protein biomarker discovery enabling researchers to measure thousands of proteins simultaneously from just a few microliters of blood. Using highly specific and thoroughly validated assays with a wide dynamic range Olinks technology overcomes traditional limitations in protein analysis and supports deeper insights into human biology and disease.

Job Description
The Quality and Regulatory function consists of Quality Systems (QS) Quality Assurance (QA) and Regulatory Affairs (RA). The Q&RA function works to ensure that products services and processes in PSXs Quality Management System (QMS) meet or exceed customer and regulatory Q&RA function establishes and maintains quality processes needed to keep PSX QMS in line with applicable standards and ensure compliance with applicable regulatory requirements.

We are now looking to hire a Quality System Manager who is responsible for establishing and maintaining the quality processes our Quality Management System for the development manufacturing and analysis of Olink biomarker panels to meet the needs of the customers. This role combines technical expertise with quality oversight to maintain robust quality management systems lead investigations drive continuous improvement and ensure ISO compliance. You will be based in our Uppsala headquarters and report to Head of Quality Systems.

A Day in the Life:

• Your impact will extend across the organization as you develop and implement procedures.
• Continuously developing and improving PSX quality processes for instance: CAPA Change control Complaint handling Document control Risk management Supplier management Internal/External audit management self-inspection programs and other relevant supporting product life cycle management processes.
• Write review and approve quality related documents.
• Lead and attend internal and external audits.
• Maintain and continuously improve the processes used to manage and resolve customer complaints related to product quality.
• Act as Process Owner for relevant processes as agreed upon ensuring alignment with company and applicable regulatory standards.
• Responsible for leading cross-functional teams and quality related meetings including providing quality metrics proposing process improvements and managing identified risks.

Technical Qualifications

• University degree in Life Science related field for instance biotechnology biology or chemistry.
• Several years experience of working with quality related tasks within Life Science.
• Experience working with specific supplier quality related tasks.
• Strong knowledge of cGMP ISO 13485/9001 and applicable regulatory requirements (FDA EMA etc.)
• Working proficiency in both Swedish and English.

Soft Skills

• The role requires strong analytical and communication skills to interface effectively with internal teams and external customers/regulators.
• Strong attention to detail while maintaining the broad perspective.
• Excellent interpersonal skills for cross-functional collaboration.
• Establish and maintain quality standards while supporting a culture of continuous improvement and compliance.

Why Join Us

At Olink Thermo Fisher Scientific you will be part of a nurturing team that values integrity innovation and involvement. We offer an encouraging environment where your diverse experiences and perspectives are appreciated enabling you to thrive and excel in your career. Come aboard and contribute significantly to global health and safety!

If you believe youre the right fit for this role we encourage you to submit your resume along with a cover letter highlighting your relevant experience. The last day for applications is on the 7th of June 2026.