Head of Quality Control and Process Care (mfd)

Work Schedule

Environmental Conditions

Job Description

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 growing efficiency in their laboratories improving patient health through diagnostics or the development and manufacture of life-changing therapies we are here to support them. Our distributed team of over 100000 colleagues provides an outstanding mix of brand new technologies purchasing convenience and pharmaceutical services across our top-tier brands like Thermo Scientific Applied Biosystems Invitrogen Fisher Scientific Unity Lab Services Patheon and PPD.

Location/Division Specific Information:

Phadia is the leading supplier of fully automatic blood analysis systems for allergy and auto-immune diseases. With our innovative products we set standards worldwide and assist clinicians in providing fast and reliable diagnoses thus helping patients at an early stage. Phadia GmbH in Freiburg is the German subsidiary of the Immunodiagnostics division of Thermo Fisher Scientific a global company that develops manufactures and distributes in vitro diagnostics in the field of allergy and autoimmune diagnostics. Our customers expect a consistently reliable and high standard of quality from our products which we ensure through innovative biochemical and medical technology solutions as well as highly qualified and motivated employees.

A Day in the Life:

The Head of Quality Control & Process Care (m/f/d) is responsible for all Quality Control testing activities and for ensuring robust capable and compliant processes throughout the product lifecycle. The role provides reliable data for product release and supports Operations QA and R&D through technical excellence.

Key Responsibilities:

Quality Control Operations

• Lead QC testing of:
  • Raw materials (including incoming inspection)
  • Semi-finished goods
  • Finished goods
• Ensure availability robustness and continuous improvement of analytical and immunological test methods
• Ensure routine testing readiness data integrity inspection readiness business continuity

Process Care & Process Validation

• Lead process care activities across the product lifecycle
• Ensure appropriate involvement in process care and process optimization process validation and revalidation as well as method lifecycle management
• Input and collaboration with R&D Product Care activities
• Approve and oversee quality-relevant validation activities within QC and production interfaces

Design Transfer Technical Execution

• Represent Operations/QC in R&D projects design transfer activities and engineering and production projects
• Support Design Transfer through method transfer and qualification
  • Definition of routine QC testing
  • Validation execution
• Ensure QC readiness before transfer into routine operations

Cross-Functional Collaboration

• Act as technical QC interface to Manufacturing Engineering R&D and QA
• Support investigations (NC Complaints CAPA) with data-driven root cause analysis

Leadership & Organization

• Lead QC and process care teams
• Manage cost center budget headcount-planning and Capex (AOP and Actuals) and monitor costs capacity and efficiency
• Provide functional and disciplinary leadership including:
  • Performance management
  • Talent development and succession planning
  • Workforce and resource planning
• Ensure a strong quality culture accountability and continuous improvement mindset
• Ensure compliance with internal policies SOPs and corporate standards
• Drive continuous improvement initiatives related to quality cost delivery and compliance
• Support operational excellence and scalability of QC processes

Keys to Success:

Education & Experience

• University degree in natural sciences medical sciences engineering or equivalent
• Several years of experience in diagnostics preferably immunoassays ELISA and IVD products
• Solid experience in Quality Control in a regulated environment
• Proven leadership experience in managing team leaders and larger teams
• Hands-on experience with regulatory frameworks such as ISO 13485 and IVDR

Technical and Regulatory Skills

• Strong understanding of:
  • QC testing and goods release processes
  • OOS CAPA complaint handling and change control
  • Validation principles and method lifecycle management
• Audit and inspection experience

Language & Systems

• German and English fluent (spoken and written)
• Strong IT skills SAP and LIMS experiences preferred

Management and Leadership

• Strong decision-making skills in a regulated environment
• Ability to balance operational efficiency and compliance
• Business acumen and experience managing budgets
• Structured risk-based problem-solving approach
• Strong stakeholder management and communication skills
• Experience working in matrix and international organizations
• Change leadership and continuous improvement mindset

What we offer:

• Employment with an innovative future-oriented organisation
• Outstanding career and development prospects
• Company pension scheme and other fringe benefits
• Exciting company culture which stands for integrity intensity involvement and innovation

If you are interested please apply online with your CV and Motivation Letter including possible start date and salary expectations.

At Thermo Fisher Scientific each one of our 100000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin disability or any other legally protected status.

Apply today!

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