Interested in a career that matters?

Key Responsibilities

• IT compliance and Documentation
• Ensure compliance of all GxP‑relevant computerized systems with regulatory guidelines (21 CFR Part 11, EU Annex 11, GAMP 5).
• Review and approve validation deliverables including Risk Assessments
• Author and maintain IT Quality SOPs.
• Maintain accurate, complete, and audit‑ready documentation.
• Computer System Validation (CSV)
• Execute and support CSV activities across the system lifecycle (implementation, change management, retirement).
• Provide guidance on validation approaches for cloud, SaaS, and on‑premise applications.
• Support periodic reviews and system requalification activities.
• Quality Assurance Support
• Participate in change control, deviation management, and CAPA processes related to IT systems.
• Conduct or support risk assessments and ensure alignment with ICH Q9 principles.
• Audit & Regulatory Support
• Support internal audits, vendor audits, and regulatory inspections.
• Prepare evidence, system documentation, and compliance reports.
• Identify and drive resolution of compliance gaps.
• Cross‑Functional Collaboration
• Work with IT, Quality, Business Owners, Vendors, and Project Teams to ensure systems meet compliance expectations.
• Provide training and guidance on CSV, data integrity, and IT compliance processes.
  
  

Handling of service tickets in collaboration with the cross functional team.

Required Qualifications

Education

• Bachelor’s degree in IT, Computer Science, Engineering, Quality, or Life Sciences.
• Advanced degrees or certifications preferred.
  
  

Experience

• 3–8 years of experience in QA, IT Quality, CSV, or regulated industry compliance.
• Experience in pharmaceutical, biotech, healthcare, or medical devices is highly preferred.
• Hands‑on experience with SDLC, validation documentation, and audit preparation.
  
  

Technical Competencies

• Strong understanding of:
• GxP and GAMP 5 guidelines
• 21 CFR Part 11 and EU Annex 11
• Data Integrity (ALCOA+) principles
• ITIL framework (preferred)
• ERP, LIMS, QMS, MES, or cloud‑based systems
  

Ability to identify compliance gaps and recommend solution

Our purpose guides the way

In Novonesis, we know that solutions rooted in biology can help solve humanity’s biggest challenges. Since we began more than a century ago, this has been our guide. It’s how we've gotten so far. And it’s how we'll impact the future. Now, more than ever, the world needs change. And with biosolutions, the possibilities for transformation are endless. If our purpose resonates with you, we encourage you to apply.

Opportunities for everyone

We are committed to an inclusive recruitment process and equal opportunity for all applicants. Therefore we ask you to apply without a cover letter or photo and instead include a few sentences in your CV explaining your motivation for applying.

We make all employment decisions based on business needs and welcome candidates with a wide range of backgrounds, including ethnicity, religion, gender, sexual orientation, age, disability, or veteran status.

Explore Other Openings

If this position isn’t the right fit, you may still find other opportunities with us. You’re welcome to explore open roles or create a job agent to stay connected with future opportunities at novonesis.com/Career