Interested in a career that matters?
Key Responsibilities:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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
Top Skills
What We Do
Novozymes has combined with Chr. Hansen to become Novonesis: linkedin.com/company/novonesis.
This global biosolutions company of 10,000 people is transforming how the world produces, consumes and lives. In 30-plus industries, its biosolutions help businesses meet their needs and the needs of our planet.
Novozymes was formed in 2000 when Novo Nordisk split into three companies: Novo Nordisk A/S, Novozymes A/S and Novo A/S. Novozymes was the world leader in biological solutions with a commitment to Rethink Tomorrow. It served 130 markets with enzymatic, microbial and advanced protein solutions. The company’s solutions enabled higher agricultural yields, low-temperature washing, energy-efficient production, renewable fuel and many other benefits.
In December 2022, Novozymes and Chr. Hansen entered into an agreement to create a leading global biosolutions partner by combining the two companies. The goal was to unleash the full potential of biosolutions and generate significant value for all stakeholders and society. The combination was completed on January 29, 2024 and Novonesis was born. The name means ‘a new beginning’ and is derived from the Greek word ‘genesis’. It reflects a new era where we’ll better our world with biology. You can find Novonesis on LinkedIn here: linkedin.com/company/novonesis.
Novozymes A/S, part of Novonesis Group.
