Job Purpose Summary
The IT Business Systems Analyst – Quality supports and administers regulated Quality systems, with primary responsibility for Veeva Vault and Thermo Fisher SampleManager LIMS. The role ensures systems remain compliant with EU MDR, FDA, ISO 13485, and GxP expectations, while supporting quality, QC and regulatory across multiple global sites. The role partners closely with business stakeholders and enterprise IT teams to support validated system changes, continuous improvement initiatives, and digital transformation efforts, without direct people‑management responsibility. What You Will Do
Provide day‑to‑day application support for Veeva Vault and Thermo Fisher SampleManager LIMS, and/or any additional quality applications Partner with Quality, QC, and Regulatory teams to translate business processes into system requirements Troubleshoot incidents and coordinate resolution with internal IT teams and vendors Support testing, validation, and controlled deployment of system changes Ensure data integrity, audit trails, and role‑based access controls across Quality systems Collaborate with ERP teams to support end‑to‑end Quality and manufacturing processes Create system documentation and deliver end‑user training Support CSV activities including IQ/OQ/PQ, change control, and periodic review Maintain inspection readiness and support internal, customer, and regulatory audits Ensure electronic records and signatures meet Part 11 and Annex 11 requirements Administer Veeva Vault QMS, including configuration, workflow management, user administration, and system maintenance in support of quality operations across medical device and pharmaceutical business units Apply the appropriate regulatory framework to each validated system engagement — 21 CFR Part 11 and EU Annex 11 for medical device systems, and 21 CFR Parts 210/211 and ICH Q10 for pharmaceutical manufacturing systems Manage change control processes for validated systems, including impact assessments, testing coordination, and documentation in compliance with established SOPs and the applicable regulatory standard Partner with Quality, Regulatory, and IT stakeholders across business units to ensure computerized systems meet applicable GxP and cGMP requirements Support audit readiness by maintaining complete and traceable validation documentation across all regulated systems Contribute to IT governance of quality systems, ensuring alignment with IT policies, data privacy requirements, and applicable regulatory obligations What you will need
Bachelor’s degree in Information Technology, Life Sciences, Business, or a related field; or equivalent education and work experience 3–5 years experience supporting Quality or Manufacturing systems in a regulated environment Strong hands‑on experience with Veeva Vault and Thermo Fisher SampleManager LIMS Understanding of Quality processes including deviations, CAPA, change control, and document management Ability to work in a regulated, multi‑site environment Strong analytical, communication, and stakeholder management skills Strong working knowledge of CSV principles and GxP validation frameworks, including IQ/OQ/PQ lifecycle and change control for validated systems Demonstrated familiarity with both medical device and pharmaceutical regulatory frameworks: 21 CFR Part 11, EU Annex 11, 21 CFR Parts 210/211, and ICH Q10 Familiarity with FDA Computer Software Assurance (CSA) guidance and its application to validation strategy Demonstrated ability to work across both commercial and regulated IT domains, managing competing priorities and stakeholder groups effectively Strong analytical, documentation, and communication skills with the ability to engage business, quality, and regulatory stakeholders Occasional travel may be required to global manufacturing sites In order to qualify for this position, applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time Was bieten wir Ihnen?
Die Zusammenarbeit in einem internationalen, motivierten und engagierten Team, das Sie bei der Einarbeitung bestmöglich unterstützen wird Die Möglichkeit, eigenständig und verantwortungsvoll zu arbeiten und Prozesse aktiv mitzugestalten Ein modernes Arbeitsumfeld mit flexiblen Arbeitszeiten Ein Bruttomonatsgehalt auf Vollzeitbasis ab EUR 5142.86 mit der Bereitschaft zur Überzahlung bei entsprechender Qualifikation Benefits: Essenszuschuss, Betriebliche Altersvorsorge, Mitarbeiterempfehlungsprogramm, Vergünstige Fitnessstudiomitgliedschaft, … Equal Opportunity
Corza Medical is an equal opportunity employer. Corza Medical evaluates qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status or other protected characteristics.
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The IT Business Systems Analyst – Quality supports and administers regulated Quality systems, with primary responsibility for Veeva Vault and Thermo Fisher SampleManager LIMS. The role ensures systems remain compliant with EU MDR, FDA, ISO 13485, and GxP expectations, while supporting quality, QC and regulatory across multiple global sites. The role partners closely with business stakeholders and enterprise IT teams to support validated system changes, continuous improvement initiatives, and digital transformation efforts, without direct people‑management responsibility. What You Will Do
Provide day‑to‑day application support for Veeva Vault and Thermo Fisher SampleManager LIMS, and/or any additional quality applications Partner with Quality, QC, and Regulatory teams to translate business processes into system requirements Troubleshoot incidents and coordinate resolution with internal IT teams and vendors Support testing, validation, and controlled deployment of system changes Ensure data integrity, audit trails, and role‑based access controls across Quality systems Collaborate with ERP teams to support end‑to‑end Quality and manufacturing processes Create system documentation and deliver end‑user training Support CSV activities including IQ/OQ/PQ, change control, and periodic review Maintain inspection readiness and support internal, customer, and regulatory audits Ensure electronic records and signatures meet Part 11 and Annex 11 requirements Administer Veeva Vault QMS, including configuration, workflow management, user administration, and system maintenance in support of quality operations across medical device and pharmaceutical business units Apply the appropriate regulatory framework to each validated system engagement — 21 CFR Part 11 and EU Annex 11 for medical device systems, and 21 CFR Parts 210/211 and ICH Q10 for pharmaceutical manufacturing systems Manage change control processes for validated systems, including impact assessments, testing coordination, and documentation in compliance with established SOPs and the applicable regulatory standard Partner with Quality, Regulatory, and IT stakeholders across business units to ensure computerized systems meet applicable GxP and cGMP requirements Support audit readiness by maintaining complete and traceable validation documentation across all regulated systems Contribute to IT governance of quality systems, ensuring alignment with IT policies, data privacy requirements, and applicable regulatory obligations What you will need
Bachelor’s degree in Information Technology, Life Sciences, Business, or a related field; or equivalent education and work experience 3–5 years experience supporting Quality or Manufacturing systems in a regulated environment Strong hands‑on experience with Veeva Vault and Thermo Fisher SampleManager LIMS Understanding of Quality processes including deviations, CAPA, change control, and document management Ability to work in a regulated, multi‑site environment Strong analytical, communication, and stakeholder management skills Strong working knowledge of CSV principles and GxP validation frameworks, including IQ/OQ/PQ lifecycle and change control for validated systems Demonstrated familiarity with both medical device and pharmaceutical regulatory frameworks: 21 CFR Part 11, EU Annex 11, 21 CFR Parts 210/211, and ICH Q10 Familiarity with FDA Computer Software Assurance (CSA) guidance and its application to validation strategy Demonstrated ability to work across both commercial and regulated IT domains, managing competing priorities and stakeholder groups effectively Strong analytical, documentation, and communication skills with the ability to engage business, quality, and regulatory stakeholders Occasional travel may be required to global manufacturing sites In order to qualify for this position, applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time Was bieten wir Ihnen?
Die Zusammenarbeit in einem internationalen, motivierten und engagierten Team, das Sie bei der Einarbeitung bestmöglich unterstützen wird Die Möglichkeit, eigenständig und verantwortungsvoll zu arbeiten und Prozesse aktiv mitzugestalten Ein modernes Arbeitsumfeld mit flexiblen Arbeitszeiten Ein Bruttomonatsgehalt auf Vollzeitbasis ab EUR 5142.86 mit der Bereitschaft zur Überzahlung bei entsprechender Qualifikation Benefits: Essenszuschuss, Betriebliche Altersvorsorge, Mitarbeiterempfehlungsprogramm, Vergünstige Fitnessstudiomitgliedschaft, … Equal Opportunity
Corza Medical is an equal opportunity employer. Corza Medical evaluates qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status or other protected characteristics.
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