Work Schedule Standard (Mon-Fri) Environmental Conditions Office 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 100,000 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 u2013 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 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionu2014enabling 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! http://jobs.thermofisher.com Agency notice! Please note we are not interested in receiving unsolicited CVs from any personnel service providers. Should you choose to send us or upload any such candidate document they will not be acknowledged and will be deleted in line with our privacy policy. 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, protected veteran status, disability or any other legally protected status.