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Tech Stack
Tools & technologiesCloud
About the role
Key responsibilities & impact- Strategic planning and independent management of IT compliance and CSV projects in regulated industries.
- Development, implementation, and optimization of tool-supported validation processes.
- Conducting gap and risk analyses and ensuring compliance with GxP regulations (FDA, EU-GMP, GAMP5).
- Validation of cloud or on-premise IT systems in agile or traditional projects.
- Advising clients on regulatory requirements and continuous improvement of validation processes.
- Using and contributing to the introduction of innovative technologies, e.g., AI-assisted validation or modern ALM tools.
Requirements
What you’ll need- At least 3–5 years of professional experience in a GxP environment and knowledge of regulatory requirements (EU/US, FDA CFR Title 21 Part 11, EU GMP Annexes 11/15, GAMP5).
- Experience in independently managing projects as well as coordinating and setting the strategic direction of validation projects.
- Familiarity with agile methods (SCRUM) and experience with tools such as JIRA and Confluence.
- Structured, analytical working style and strong quality awareness.
- Excellent communication skills in German (C1 level) and English.
- Experience with ALM tools or AI-assisted validations is a plus.
Benefits
Comp & perks- Permanent employment with stability: We have been operating since 1994!
- Flexible working hours: You can organize your working time freely within flexitime.
- Location-independent work: We provide a modern, well-equipped workplace and additionally offer the option for mobile/remote work.
- Onboarding program: You will be supported by a mentor to help you settle in quickly.
- Family-friendly company: We support you and your family, e.g., with childcare subsidies and 5 days of paid child sick leave with 100% salary continuation.
- Attractive compensation packages: You receive an annual salary, additional vacation days, and paid special leave for certain occasions.
- Overtime is compensated with time off in lieu or paid with a 25% surcharge.
- Individual coaching: We offer opportunities for professional development and tailored training programs.
- Company events: We regularly organize social events for you and your colleagues focused on fun and team spirit.
- Bike leasing: We offer the option to lease bicycles on attractive terms for private and business use.
- Employee benefits and company social benefits: You enjoy many corporate benefits, e.g., a company pension scheme with employer contributions, accident insurance valid for private use, rotating course offerings in cooperation with the Techniker Krankenkasse, discounts at Pfitzer Group fitness studios, and a company headquarters with employee parking.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
IT complianceCSV projectsvalidation processesgap analysisrisk analysisGxP regulationscloud IT systems validationagile project managementtraditional project managementAI-assisted validation
Soft Skills
strategic planningindependent managementclient advisingcontinuous improvementstructured working styleanalytical working stylequality awarenessexcellent communication