Head of Quality Systems

Posted 6 Days Ago
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Uppsala
In-Office
Senior level
Biotech
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
The Role
Lead quality assurance and regulatory compliance, develop and maintain quality management systems, manage a team, and ensure product standards.
Summary Generated by Built In

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Location/Division Specific Information

The Head of Quality Systems position at Olink, part of Thermo Fisher Scientific presents an exceptional opportunity to lead and innovate within a top-level team committed to achieving excellence in quality management.

Discover Impactful Work:

Join us to drive quality assurance and regulatory compliance, ensuring our products meet the highest standards. Your work will be crucial in maintaining our reputation for flawless quality and customer happiness. In this role, you will be based in our Uppsala headquarters and report to Director Quality & RA.

A day in the Life:
  • Define and implement QMS strategies. Develop, implement, and maintain the QMS in accordance with relevant regulatory standards (e.g., ISO 9001, ISO 13485, GMP).

  • Continuously develop and improve the Olink Quality processes, for instance CAPA, Change control, Complaint handling, Document Control, Risk management, Supplier management.

  • Lead the preparation, execution, and follow-up of internal and external audits, including customer audits, notified body audits and regulatory inspections if applicable.

  • Collaborate with procurement and supply chain teams to ensure suppliers meet the required quality standards.

  • Lead and develop a dedicated team.

Keys to Success:

Education

  • University degree in chemistry, biochemistry, molecular biology, or equivalent experience.

Experience
  • Several years of experience in a leadership role.

  • Extensive experience in quality-focused roles within Life Science.

  • Proven leadership in quality functions and regulated environments.

Knowledge, Skills, Abilities
  • Deep knowledge of ISO standards and FDA regulations.

  • Excellent communication skills in Swedish and English.

  • Strong collaboration and leadership abilities.

Physical Requirements / Work Environment

This role requires a dynamic work environment, with occasional travel for audits and training. You will lead a team in a fast-paced, innovative setting.

The last application date is on the 19th of December 2025.

Benefits

We provide competitive compensation, yearly bonus plan, healthcare coverage, and various employee perks. Thermo Fisher Scientific offers opportunities to work in a forward-looking, creative company with excellent career growth potential. Our company culture embodies integrity, passion, engagement, and creativity!

Top Skills

Gmp
Iso 13485
Iso 9001
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The Company
HQ: Waltham, MA
100,000 Employees

What We Do

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Why Work With Us

You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.

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