Department – IT Quality
Are you motivated by challenges and a dynamic work environment? Do you excel in roles requiring close collaboration with key stakeholders and strategic alignment? Are you driven by a can-do attitude and a commitment to continuous improvement? If so, we may have the perfect opportunity for you. Apply now to join our growing team and work in an international environment.
The Position
Role: Advanced IT Quality Advisor
As an Advanced IT Quality Advisor, you will:
- Coordinate IT QA Activities: Oversee QA activities for IT systems, services, and projects in your portfolio.
- Provide SME Support: Offer expert guidance on quality processes to System/Service/Project Managers, ITQCs, and SMEs.
- Ensure Quality Compliance: Approve quality documents, advise on quality matters, and assist in addressing compliance gaps identified during audits and inspections.
- Coach and Guide: Mentor ITQC and SME employees on quality and compliance tasks or stakeholder issues.
- Maintain Standards: Ensure IT systems/services comply with internal and international standards and regulations.
- Pass Inspections: Ensure systems/services pass regulatory inspections smoothly.
Qualifications
- Education: Bachelor’s degree in a relevant field.
- Experience: 9 – 11 years of experience, including:
- 3+ years in GLP/GMP/GCP/pharmacovigilance areas.
- 3+ years as a quality responsible/project manager.
- 3+ years in IT QA work in GxP areas.
- Skills:
- Experience with Software Development Life Cycle (SDLC) review and approval.
- Knowledge of IT system risk assessment.
- Exposure to 21CFR Part 11 and GAMP 5.
- Experience with periodic reviews, change request management, deviation management, IT vendor audit management, and Safe Agile is a plus.
About the Department
ITQA is an extension of Denmark, supporting various system/service portfolios across Global IT and IO affiliates. We manage ITQA tasks for corporate GxP IT systems, RPA, and parts of PS infrastructure. Our focus is on delivering high-quality services through simple and agile processes to ensure compliance. The ITQA team provides three main services:
- Quality Management
- Quality Assurance
- Quality Support
Working at Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of combating serious chronic diseases. As we expand beyond diabetes, we impact over 40 million patients daily and are among the world’s top 20 companies by market cap. Our success depends on the collective potential of our 63,000 employees worldwide. We value diverse skills and perspectives and are committed to fostering an inclusive environment. At Novo Nordisk, we work together towards a greater goal, making a life-changing impact.
Contact
To submit your application, please upload your CV online by clicking "Apply" and following the instructions.
Deadline: September 9, 2024.
Disclaimer
Beware of fraudulent job offers claiming to be from Novo Nordisk or its affiliates. These may come from individuals or organizations posing as Novo Nordisk recruiters or representatives. Novo Nordisk does not extend unsolicited employment offers, nor does it charge prospective employees fees or request funding as part of the recruitment process.
Our Commitment to Diversity
At Novo Nordisk, we aspire to be the best company for the world, recognizing that this is only possible with a diverse and talented workforce. We are dedicated to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve, and the communities we operate in. Together, we’re life-changing.
