IT VAL &Comp specialist

Department: DD&IT
Are you an agile and passionate leader in pharmaceutical compliance? Do you thrive in regulated markets and excel in quality system management? If so, we invite you to join our team as a Pharmaceutical Compliance Leader at Novo Nordisk. Read more and apply today for a life-changing career.
About the Department
Digital, Data & IT - Product Supply GBS is the unit responsible for many global IT systems at Novo Nordisk including the operation, maintenance, support, and development of these systems. The systems are used on a global scale across business areas and are critical to the execution of key business processes such as manufacturing and supply chain etc.
The position
As a Pharmaceutical Compliance Leader at Novo Nordisk, you will:

• Provide expertise in validation, ensuring compliance with current industry regulations, guidelines, and trends.
• Support end-to-end audits and inspections, ensuring robust inspection readiness for GxP systems and finding solutions to compliance gaps identified in audits/inspections.
• Drive continuous improvement in product quality and compliance systems.
• Review master and complete qualification and validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria and manage end-to-end validation activities throughout the project and operations phase, including review, approval, and authorization of validation deliverables.
• Lead timely quality system implementation and handle end-to-end validation for systems by adhering to QMS and guide team members and manage processes to ensure compliance and quality.

Qualification
We are looking for a candidate with the following qualifications:

• Bachelor's degree (B. Tech) in Electronics and Communication.
• 10+ years of experience with IT and relevant experience in Software Testing Lifecycle and Computer System Validation (CSV) across life sciences and healthcare domains.
• Excellent communication skills to coordinate with stakeholders and ensure quality work.
• Ability to represent Novo Nordisk in relations with users and external stakeholders.
• Expertise in test delivery management, QMS, SQA activities, process assessments, testing activities, 21 CFR 11, 21 CFR 820 regulatory requirements, GxP compliance, and good documentation practices.
• Strong focus on patient safety, product quality, validated state, and regulatory impact.
• Drive for QMS expectations and reflect the same in all deliverables.
• Ability to take end-to-end ownership to deliver on-time with quality.
• Eagerness to improve and inspire the team.
• Ability to swiftly transform to raise quality/excellence, simplify, and standardise.
• Effective decision-making skills and problem-solving mindset.

Working at Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognise the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further. Together, we're life changing.
Contact
For further information please contact or get to know us better by visiting www.novonordisk.com/careers.
Deadline
Apply by 31st October 2024.
Disclaimer
It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.