Senior Product Specialist:Compliance & Quality for Regulated Industries-Digital Manufacturig (f/m/d)

Job description

We help the world run better At SAP, we keep it simple: you bring your best to us, and we'll bring out the best in you. We're builders touching over 20 industries and 80% of global commerce, and we need your unique talents to help shape what's next. The work is challenging – but it matters. You'll find a place where you can be yourself, prioritize your wellbeing, and truly belong.

What's in it for you? Constant learning, skill growth, great benefits, and a team that wants you to grow and succeed.

What you’ll do Summary

We are seeking a Senior Product Specialist (f/m/d) to define, lead, and execute upon a product strategy targeted to regulated industries for our SAP Digital Manufacturing solution within SAP’s Autonomous Enterprise. We are looking for highly motivated, experienced and hands-on IT Quality and Compliance personnel. In this role you will help us design, conceptualize, and build new quality strategies to keep our products in compliance against 21 CFR Part 11, EU Annexure 11, Good Automated Manufacturing Practices (GAMP) etc.

The Role

• Responsible for GxP Quality Assurance in Software Development Lifecycle (SDLC) and related Operations such as change management, risk management, audit management, supplier management etc.
• Support in the implementation and maintenance of the SAP Digital Manufacturing (DM) Validation Concept and creation of all necessary SAP DM/ Manufacturing Execution System validation preferred.
• Strong knowledge of FDA, GxP, 21 CFR Part 11/820, GAMP, and software validation/go-live procedures.
• Expertise in process or discrete manufacturing in ERP and MES; SAP DM or related SAP products are a plus
• Proven expertise in implementing AI in regulated environments.
• Experience with risk-based validation approaches
• Strong analytical, planning, coordination, and technical writing skills, with the ability to manage complex activities
• High affinity for IT solutions and ability to translate complex technical topics into clear, understandable content
• Fluent English; German is a plus Meet your team The Digital Manufacturing unit is a global, diverse team successfully delivering Cloud/Edge solutions to SAP customers across multiple industries and within the Autonomous Enterprise for manufacturing ​ Bring out your best 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. At SAP, you can bring out your best. We win with inclusion 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 world. SAP is committed to the values of Equal Employment Opportunity and provides accessibility accommodations to applicants with physical and/or mental disabilities.

If you are interested in applying for employment with SAP and are in need of accommodation or special assistance to navigate our website or to complete your application, please send an e-mail with your request to Recruiting Operations Team: [email protected].

For SAP employees

Only permanent roles are eligible for the SAP Employee Referral Program, according to the eligibility rules set in the SAP Referral Policy. Specific conditions may apply for roles in Vocational Training. AI Usage in the Recruitment Process For information on the responsible use of AI in our recruitment process, please refer to our Guidelines for Ethical Usage of AI in the Recruiting Process. Please note that any violation of these guidelines may result in disqualification from the hiring process.

Requisition ID

460148 | Work Area: Solution and Product Management | Expected Travel: 0 - 10% | Career Status: Professional | Employment Type: Regular Full Time | Additional Locations: #LI-Hybrid ​