GxP Compliance Senior Specialist

<p><b>We help the world run better </b></p> <p>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.</p> <p> </p> <p><strong><span>What you’ll do:</span></strong></p> <p> </p> <p><span>As a GxP </span><span>Senior Specialist at SAP SGSC, you will be responsible for creating and maintaining GxP compliance strategies for SAP's solutions catering to the Life Sciences market. You'll play a pivotal role in shaping GxP-ready processes and controls ensuring that SAP solutions deliver 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</span></p> <ul> <li><span>Develop and maintain GxP compliance strategies for SAP's public cloud solutions.</span></li> <li><span>Design GxP-ready processes and controls.</span></li> <li><span>Provide expert guidance on regulatory requirements (e.g., FDA 21 CFR Part 11, EU GMP Annex 11) to internal teams and customers.</span></li> <li><span>Assist in internal and external audits as well as regulatory inspections related to GxP compliance.</span></li> <li><span>Stay current with evolving GxP regulations and industry best practices, ensuring SAP remains at the forefront of compliance.</span></li> <li><span>Conduct risk assessments and gap analyses of current systems against GxP requirements.</span></li> <li><span>Collaborate with development teams to ensure GxP considerations are integrated into product design and development lifecycle.</span></li> </ul> <p> </p> <p><strong><span>What you bring:</span></strong></p> <ul> <li><span>At least 5+ years of GxP Experience</span></li> <li><span>7+ years of overall experience in Life Sciences Industry in Security or GxP related roles.</span></li> <li><span>Proven track record of successfully driving the compliances of products</span></li> <li><span>Strong communication skills to engage effectively with customers and internal stakeholders, building trustful and lasting relationships</span></li> <li><span>Comprehensive understanding of GxP-regulated industries, with a strong focus on Life Sciences</span></li> <li><span>Strong analytical skills with the ability to translate data into actionable insights</span></li> <li><span>Bachelor's degree in Computer Science, Engineering, Business, or related field</span></li> <li><span>Demonstrated ability to balance customer needs, technical constraints, and business objective</span></li> </ul> <p> </p> <p><strong><span>Meet your team:</span></strong></p> <p><span>Fostering SAP’s cloud strategy, Industry Product Engineering (IPE) reinvents businesses by building new, industry-specific applications for strategic markets on BTP, providing customers with essential solutions for their business transformation.</span></p><p><span><span><span id="cke_bm_1617S"> </span></span></span>​<b>Bring out your best</b></p> <p><span>SAP innovations help more than four hundred thousand customers worldwide work together more efficiently and use business insight more effectively. Originally known for leadership in enterprise resource planning (ERP) software, SAP has evolved to become a market leader in end-to-end business application software and related services for database, analytics, intelligent technologies, and experience management. As a cloud company with two hundred million users and more than one hundred thousand employees worldwide, we are purpose-driven and future-focused, with a highly collaborative team ethic and commitment to personal development. Whether connecting global industries, people, or platforms, we help ensure every challenge gets the solution it deserves. </span>At SAP, you can bring out your best.</p> <p><b>We win with inclusion</b></p> <p>SAP’s culture of inclusion, focus on health and well-being, and flexible working models help ensure that everyone – regardless of background – feels included and can run at their best. At SAP, we believe we are made stronger by the unique capabilities and qualities that each person brings to our company, and we invest in our employees to inspire confidence and help everyone realize their full potential. We ultimately believe in unleashing all talent and creating a better and more equitable world.<br/> SAP is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to the values of Equal Employment Opportunity and provide accessibility accommodati