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

SAP
Germany
Workplace: HybridFull timeFunction: Legal, Risk & ComplianceExperience: 4+ yearsSkills: ["Analytical","Planning","Coordination","Technical writing","Risk-based validation","Clear communication","Translation of technical topics"]

Define and execute product strategy for regulated industries within SAP Digital Manufacturing under the Autonomous Enterprise. Own GxP Quality Assurance across the software development lifecycle and related operations like change, risk, audit, and supplier management. Support validation concepts, continuous revalidation, supplier/customer audits, and translate ISO content into ISPE GAMP format. Drive product vision and roadmap for digital manufacturing in AI-enabled regulated environments.

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FursaFursa
SAP
SAP
17 hours ago

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

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Source: Company careers pageValidated by: Fursa AI
Last checked: 17 hours agoStatus: Live

Job Summary

Define and execute product strategy for regulated industries within SAP Digital Manufacturing under the Autonomous Enterprise. Own GxP Quality Assurance across the software development lifecycle and related operations like change, risk, audit, and supplier management. Support validation concepts, continuous revalidation, supplier/customer audits, and translate ISO content into ISPE GAMP format. Drive product vision and roadmap for digital manufacturing in AI-enabled regulated environments.
Location: Germany
Workplace: Hybrid
Employment Type: Full time
Job Function: Legal, Risk & Compliance

Key Responsibilities

  • •Define and execute product strategy for regulated industries for SAP Digital Manufacturing within Autonomous Enterprise.
  • •Lead GxP Quality Assurance in the SDLC and related operations including change, risk, audit, and supplier management.
  • •Support implementation/maintenance of the SAP Digital Manufacturing validation concept and creation of required documentation.
  • •Support design and implementation of continuous revalidation for Digital Manufacturing and operational transformation of ISO content into ISPE GAMP format.
  • •Develop and deliver DM product vision and roadmap, including AI in regulated environments, and support supplier/customer audits with required documents.
Travel: Low travel

Key Requirements

  • •4+ years’ experience in consulting, product engineering, or product management of computerized system validation in regulated industries (Pharma, Life Sciences, Biotech, Medical Devices).
  • •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 Digital Manufacturing or related SAP products are preferred.
  • •Proven experience implementing AI in regulated environments and using risk-based validation approaches.
  • •Strong analytical, planning, coordination, and technical writing skills; ability to translate complex technical topics into clear content; fluent English (German a plus).
Experience:4+ yearsRegulated industriesPharmaLife SciencesBiotechMedical Devices
Skills:AnalyticalPlanningCoordinationTechnical writingRisk-based validationClear communicationTranslation of technical topics
Languages:EnglishGerman
Tech Stack:SAP Digital ManufacturingSAPERPMESAIGxP21 CFR Part 1121 CFR 820GAMPISPE GAMPISO

Company Brief

SAP
Global enterprise software company best known for ERP systems and business applications covering finance, supply chain, procurement, HR, analytics, and customer management for large organizations.
Industry: Enterprise Software
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Walldorf, Germany
Founded: 1972
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