Application Manager - Veeva Quality

Location: gdansk 80-309, Poland, Poland 
Contract type: Permanent 
Job ID: 2619 

Shape the LEO Pharma of tomorrow   

At LEO Pharma, our mission transcends the conventional. We're on an ambitious path to become the leaders in medical dermatology worldwide. If you're ready to make a difference, this role is your gateway to a world of opportunities! 

In IT Process & Compliance we share a “challenge accepted” mindset and are guided by our winning behaviours of simplification, collaboration, and accountability, to achieve our goals. 
 

Application Manager  

Are you an experienced IT professional with a passion for maintaining and improving quality systems within the pharmaceutical industry? Do you thrive in a dynamic environment where your expertise ensures compliance and enhances user experiences? At LEO Pharma, we are dedicated to helping people achieve healthy skin through innovative treatments. We invite you to join our R&D and Quality Application Management team in Gdansk, Poland, where you will play a pivotal role in managing and optimizing our Quality Vault applications. 

Your Role 

• As an Application Manager you will be responsible for keeping the Quality Vault in an operational, validated state, building competencies within the RDQ Application Management team, ensuring alignment across Quality Vault applications, and addressing the needs of business users for continuous improvement. Your key responsibilities will include: 
• Execute Quality Vault Periodic Review in collaboration with CQ Process and Systems team, HCL, Veeva and IT etc. 
• Maintain Quality Vault – URS, System Manuals, Risk Assessments and other relevant Quality Vault IT-related documents. 
• Support system owners, maintain application lifecycle roadmaps, manage risks and regulatory requirements, and ensure compliance with GxP IT validation standards. 
• Build a strong technical culture emphasizing technical excellence, security, and user experiences. 
• Provide input to the yearly budget process, manage change requests, and develop proposals to enhance the Quality Vault solution. 
• Communicate relevant matters to stakeholders, lead CAPA, deviations, change actions, and participate as a subject matter expert in audits/inspections. 

Your Qualifications 

To excel in this role, you will need: 

• A bachelor’s or higher degree in computer science, engineering, business, or equivalent. 
• Veeva vault certification
• Relevant work experience, preferably within the pharmaceutical industry (GxP, IT compliance, and release/validation activities). 
• Solid experience (2-4 years) within application management. 
• Experience in reviewing documentation such as user requirements, release notes, and validation plans/reports. 
• Full proficiency in both written and spoken English. 
• Functional and technical understanding of relevant solutions and integration with third-party, on-premise, and cloud-based platforms. 
• The ability to quickly comprehend the functions and capabilities of new technologies. 
• Strong organizational skills, stakeholder management, and the ability to work in a changing environment with tight deadlines and diverse cultures. 

Specific responsibilities for the Application Manager are:
-    Manage Quality Vault releases in collaboration with the CQ Process and Systems team, HCL, Veeva and IT.
-    Support System Owner and System Owner delegate to maintain Veeva application lifecycle roadmap, manage risk and regulatory requirements and ensure owned applications are available and comply with security and application management standards

-    Provide input to the yearly budget process for the applications within area of responsibility
-    Ensuring compliance and adherence to GxP IT validation standards for GxP IT systems, including but not limiting to: 
-    Lead activities around CAPA, Deviations & Change Actions within area of responsibility
-    Lead activities around Periodic Review of GxP Documentation within area of responsibility
 

Your New Team 

Welcome to the R&D and Quality Application Management team at LEO Pharma! You will join a dedicated group of professionals committed to ensuring our organization's quality systems are robust and effective. Reporting to the Head of RDQ Application Management, you will collaborate closely with various internal departments and external partners. Our team values open communication, collaboration, and a shared commitment to excellence, continually pushing the boundaries to deliver innovative solutions. 

Contact and Application 

Ready to take the next step in your career? Apply now to join LEO Pharma. We look forward to receiving your application! 

At LEO Pharma, we believe in the power of teamwork and the potential of every individual. Join us and be part of a company that is making a real difference in the world of pharmaceuticals. Apply today and seize this incredible opportunity to build new areas in a land full of possibilities. 

You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.  

Beyond the skin  

Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact.  Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet.   

At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a difference.  

For certain positions, LEO Pharma might complete a background check conducted by a third party.  

Join us on our journey Beyond the Skin. Apply today!