Your mission
In this role you are responsible for ensuring that all our IT systems supporting GxP activities are compliant with applicable regulatory requirements and they are validated throughout their entire lifecycle. Acting as a key stakeholder to IT, Quality Assurance and the business, this position enables secure, efficient and inspection-ready digital solutions, supporting regulated operations.
Key Responsibilities:
* Ensure GxP-compliant operation and lifecycle validation of IT systems in line with GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+, and related regulations.
* Own and maintain IT QMS documentation; manage IT-related risk assessments, CAPAs, deviations, and change controls.
* Lead and support CSV activities from system classification and validation planning through testing, release, and decommissioning.
* Validate a wide range of systems including clinical, laboratory, manufacturing, ERP, document management, and cloud/SaaS solutions.
* Ensure vendor assessment and supplier qualification using risk-based, scalable validation approaches.
* Bridge IT, Quality, and business interests, providing guidance during implementations, upgrades, and audits.
* Review and approve validation deliverables and train system owners and users on compliance expectations.
Your profile
* Degree in Computer Science, Life Science, Engineering, Quality or related field.
* 5-7+ years of experience in IT Compliance / Computer System Validation in the Biotech or Pharma environment.
* Skilled in GAMP 5, 21 CRF Part 11, EU Annex 11 and Data Integrity, and experience with cloud / SaaS validation.
* Proven experience with GxP computerized systems and supporting regulatory inspections.
* Knowledge of SDLC, agile delivery models, cybersecurity and data privacy as well as macOS is beneficial.
* Pragmatic, risk-based mindset with a strong eye for detail and high documentation standards.
* Excellent communication and collaboration skills to effectively and constructively drive change in a fast-paced, evolving digital environment.
* Business-fluent in English.
Why us?
* A permanent full-time position in an international and highly motivated team.
* A dynamic, flexible and innovative working environment.
* Participation in our company’s success through our stock option program.
* Competitive compensation, comprehensive benefits and opportunities for professional growth.
* Further benefits that promote our employee’s health and wellbeing: Wellpass, OpenUp, and more.
Join us and be part of a company where your work directly contributes to our mission of improving patient care through groundbreaking research. Immunic AG offers a stimulating work environment where innovation and collaboration are valued.
About us
Immunic Therapeutics is a dynamic biotechnology company with a pipeline of selective, orally available immunology therapies for the treatment of chronic inflammatory and autoimmune diseases. Currently, three small molecule product candidates are in various stages of clinical development. For more information, please visit: www.imux.com.