Life Science Consultant, LIMS QA Expert

KVALITO AG; München; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading consulting firm is seeking a LIMS QA Expert to ensure compliance and quality assurance for Laboratory Information Management Systems in regulated environments. The successful candidate will collaborate with IT, Quality, and Laboratory teams, ensuring validated and audit-ready systems. Ideal applicants will have a degree in Life Sciences or related fields, 3-7 years of QA experience with LIMS, and proficiency in English and German.

Qualifikationen

• 3-7 years of experience in QA roles focused on computerized systems, preferably LIMS.
• Hands-on experience with LIMS platforms and computerized system validation (CSV).
• Proficiency in English and German (oral and written).

Aufgaben

• Ensure LIMS compliance with GxP, FDA 21 CFR Part 11, and Data Integrity principles.
• Review, approve, and maintain validation documentation.
• Support and execute validation activities during new LIMS implementations.

Kenntnisse

Regulatory compliance

Quality assurance

Data integrity

Communication

Analytical skills

Ausbildung

Bachelor's or Master's degree in Life Sciences, Computer Science, Engineering or related discipline

Tools

LIMS platforms (e.g., LabWare, LabVantage, SampleManager)

QC-related systems (e.g., ELN, Empower)

Jobbeschreibung

Join Our Team of Enthusiasts!

At KVALITO Consulting Group, a women-owned business founded in 2013, we are dedicated to transforming the life sciences and healthcare sectors through tailored, innovative solutions that prioritize quality and people. Guided by our vision to lead with talent and transform with purpose, we are committed to creating lasting, high-value relationships with our clients and empowering high-performing individuals to reach their full potential.

At KVALITO, we embrace diversity, equity, and inclusion in every aspect of our work, fostering a results-oriented, ambitious, and caring culture. Our purpose-driven team is agile and adaptable, ready to learn and respond to evolving business needs. Together, we champion a culture that balances excellence with empathy, utilizing technology and human-centric approaches to drive impactful results.

If you're passionate about making a difference and eager to grow within a company that values inclusivity and high performance, KVALITO could be the place for you. Join us in creating transformative solutions that empower our clients and leave a legacy of excellence in consulting.

Learn more about us at : www.kvalito.ch

Life Science Consultant, LIMS QA Expert

Position : LIMS QA Expert

Location : Germany

Mission :

As a LIMS QA Expert, you will ensure the compliance, validation, and quality assurance of Laboratory Information Management Systems (LIMS) in GxP-regulated environments. Your mission is to guarantee that LIMS implementations, upgrades, and operations meet international regulatory standards (21 CFR Part 11, EU Annex 11) and company SOPs, while supporting laboratory operations with reliable, validated, and audit-ready systems.

You will collaborate with IT, Quality, and Laboratory teams to oversee validation deliverables, risk assessments, and system lifecycle management, ensuring data integrity and regulatory compliance across the enterprise.

Key Accountabilities :

• Ensure LIMS compliance with GxP, FDA 21 CFR Part 11, EU Annex 11, and Data Integrity principles.
• Review, approve, and maintain validation documentation (URS, FS, DS, IQ, OQ, PQ, Test Scripts, Traceability Matrix).
• Support and / or execute validation activities during new LIMS implementations, upgrades, and data migrations.
• Lead QA oversight for change controls, deviations, CAPAs, and risk assessments related to LIMS.
• Partner with business and IT stakeholders to ensure controlled and compliant system lifecycle management.
• Conduct periodic reviews of LIMS systems and ensure readiness for internal and external audits.
• Provide QA expertise during regulatory inspections, acting as SME for LIMS validation and compliance topics.
• Review and approve LIMS-related SOPs, training materials, and work instructions.

Key Qualifications :

Education & Experience :

Bachelor's or Master's degree in Life Sciences, Computer Science, Engineering, or a related discipline.

3-7 years of experience in QA roles focused on computerized systems, preferably LIMS.

Hands-on experience with LIMS platforms (e.g., LabWare, LabVantage, SampleManager, Thermo Fisher).

Experience in computerized system validation (CSV) within a GxP pharmaceutical or biotech environment.

Proficiency in English and German (oral and written) is mandatory, additional languages are a plus.

Technical Skills :

Solid understanding of GxP, GAMP5, CSV, 21 CFR Part 11, Annex 11 requirements.

Strong knowledge of data integrity and audit trail principles.

Familiarity with QC-related systems (e.g., ELN, CDS, Empower, LES) is an advantage.

Experience preparing for and supporting audits / inspections.

Key Competencies :

Strong analytical, documentation, and problem-solving skills.

Confident communicator, able to explain QA and validation principles to technical and non-technical stakeholders.

Structured, detail-oriented, and quality-focused mindset.

Ability to work independently in a global, remote, and cross-functional environment.

You :

Are driven by impact, passionate about shaping the future of Life Sciences and healthcare through technology and innovation.

Believe in open communication, speak up, challenge ideas, and engage in meaningful discussions, even with leadership.

Focus on solutions, not problems, take a proactive approach, looking for ways to improve rather than assigning blame.

Own your work, take responsibility and accountability seriously, no matter how challenging the situation.

Commit to excellence, delivering high-performance results while embracing sustainable practices in everything you do.

We :

Strive to be the best; our mission is to become the world's leading consulting company, empowering high-performing individuals, regardless of gender or neurotype, to reach their full potential and leave a lasting legacy of diversity, equality, inclusion, and excellence.

Foster a culture of respect, value integrity, fairness, and the unique contributions of every team member.

See mistakes as opportunities, embrace challenges, learn from them, and continuously improve.

Prioritize potential over experience, believe intelligence, values, and growth matter more than the number of years on a résumé.

Contact

If you are driven, innovative, and eager to make an impact in Life Sciences consulting, we would love to hear from you.

To apply, send your application to recruiting(at)kvalito.ch , including, your :

CV, motivation letter, and supporting documents (diplomas, certificates, references)

Availability, including earliest start date

Salary expectations

Location preference

We believe in potential, values, and growth -so if this role excites you, let's connect!

Your KVALITO Team.