GxP Expert

At SAP, we enable you to bring out your best. Our company culture is focused on collaboration and a shared passion to help the world run better. How? We focus every day on building the foundation for tomorrow and creating a workplace that embraces differences, values flexibility, and is aligned to our purpose-driven and future-focused work. We offer a highly collaborative, caring team environment with a strong focus on learning and development, recognition for your individual contributions, and a variety of benefit options for you to choose from.

What youll do:

As a GxP Expert at SAP IPE, you will be responsible for creating and maintaining GxP compliance strategies for SAP's Life Sciences solutions. You'll play a pivotal role in shaping the product strategy, driving innovation, and ensuring the product delivers exceptional value to our customers keeping GxP in perspective. This position requires deep industry knowledge in the Life Science Industry, and the ability to collaborate across various teams to bring a successful and compliant product to market

• Develop and maintain GxP compliance strategies for SAP's Life Sciences solutions, also focusing on S/4 HANA public cloud.
  
• Conduct risk assessments and gap analyses of current systems against GxP requirements.
  
• Design and implement GxP-compliant processes and controls within our software solutions.
  
• Collaborate with development teams to ensure GxP considerations are integrated into product design and development lifecycle.
  
• Provide expert guidance on regulatory requirements (e.g., FDA 21 CFR Part 11, EU GMP Annex 11) to internal teams and customers.
  
• Assist in customer audits and regulatory inspections related to GxP compliance.
  
• Stay current with evolving GxP regulations and industry best practices, ensuring SAP remains at the forefront of compliance.
  
• Be accountable for the success of the industry product(s), ensuring SAPs products deliver on customer expectations.
  

What you bring:

• Atleast 5+ years of GxP Experience
  
• 10+ years of overall experience in Life Sciences Industry in Security or GxP related roles.
  
• Proven track record of successfully driving the compliances of products
  
• Strong communication skills to engage effectively with customers and internal stakeholders, building trustful and lasting relationships
  
• Comprehensive understanding of GxP-regulated industries, with a strong focus on Life Sciences, ideally Clinical Trials Management
  
• Strong analytical skills with the ability to translate data into actionable insights
  
• Experience with agile methodologies and product development best practices
  
• Ability to advocate industry thought leadership both internally and externally.
  
• Bachelor's degree in Computer Science, Engineering, Business, or related field
  
• Demonstrated ability to balance customer needs, technical constraints, and business objective