Head of Quality Systems at Thermo Fisher Scientific

Uppsala, Uppsala County, Sweden

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Life Sciences, Medical DevicesIndustries

Requirements

University degree in chemistry, biochemistry, molecular biology, or equivalent 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
Deep knowledge of ISO standards (e.g., ISO 9001, ISO 13485) and FDA regulations
Excellent communication skills in Swedish and English
Strong collaboration and leadership abilities

Responsibilities

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 Olink Quality processes (e.g., 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

Skills

Key technologies and capabilities for this role

QMSISO 9001ISO 13485GMPCAPAChange ControlComplaint HandlingDocument ControlRisk ManagementSupplier ManagementAuditsRegulatory Compliance

Questions & Answers

Common questions about this position

What compensation and benefits are offered for this role?

The position offers competitive compensation, a yearly bonus plan, healthcare coverage, and various employee perks.

Is this role remote or does it require office presence?

This role is based in the Uppsala headquarters and requires presence in a dynamic office environment with occasional travel for audits and training.

What skills and experience are required for the Head of Quality Systems role?

Candidates need a university degree in chemistry, biochemistry, molecular biology or equivalent, several years in a leadership role, extensive experience in quality-focused roles within Life Science, deep knowledge of ISO standards and FDA regulations, plus excellent communication skills in Swedish and English.

What is the company culture like at Thermo Fisher Scientific?

The culture emphasizes impactful work, innovative thinking, customer focus, passion, unique contributions, and empowering colleagues in a fast-growing global organization.

What makes a strong candidate for this position?

A strong candidate will have proven leadership in quality functions within regulated Life Science environments, deep expertise in ISO standards and FDA regulations, and strong collaboration and leadership abilities, along with fluency in Swedish and English.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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