ERP Solution Consultant - SAP Quality
About the job
- Demonstrated experience working and leading independently to deliver complex solution designs and products within the enterprise resource planning area.
- A proven track record of driving the successful completion of major programs or product milestones, frequently functioning in a leadership, technical lead, or product owner role.
- Experience contributing to talent acquisition and capability development, including mentoring, interviewing, and organizing training.
- Advanced knowledge of enterprise resource planning information technology concepts and practices, with general and in-depth knowledge in one or two specific enterprise resource planning and technology areas.
- Extensive understanding of tools, principles, concepts, and techniques related to requirements, data, usability, and process analysis.
- Good knowledge of architecture practices and the ability to document and evolve architecture throughout the product life cycle.
- Intermediate-level business process domain knowledge.
- Hands-on configuration experience with SAP Batch Release Hub for Life Sciences.
- Proven experience navigating SAP Business Technology Platform Cockpit, Cloud Foundry, SAP Integration Suite, Extension Suite, Destination Service, and Identity Authentication Service.
- Strong background in SAP S/4HANA Quality Management, Materials Management, Production Planning for Process Industries, Core Data Services views, and SAP HANA database querying.
- Solid knowledge of OData, REST APIs, JSON and XML handling, and middleware integration patterns connecting SAP and non-SAP platforms.
- A minimum of 3–5 years of experience in the life sciences, pharmaceuticals, or biotechnology sector.
- In-depth understanding of Good Manufacturing Practice, electronic signatures under 21 CFR Part 11, audit trails, and Computer Software Validation frameworks.
- A Bachelor's or Master's degree in Computer Science, Information Technology, Pharmacy, Industrial Engineering, or a related field.
- Strong problem-solving, analytical, and communication skills to bridge technical delivery teams with quality business users.
- Strong collaboration and inclusion capabilities, including resolving conflicts at the team level and fostering effective teamwork across project workstreams.
- A high level of self-direction and initiative, with the ability and willingness to learn independently and stay informed about new technologies and concepts.
- Lead end-to-end implementation and configuration of SAP Batch Release Hub for Life Sciences on SAP Business Technology Platform.
- Architect cross-system data flows between SAP S/4HANA Quality Management, Materials Management, and Production Planning for Process Industries; third-party Laboratory Information Management Systems; Manufacturing Execution Systems; and Document Management Systems into the Batch Release Hub.
- Design data models and leverage SAP HANA database capabilities to support high-performance querying and aggregation of batch genealogy, inspection lots, and regulatory release data.
- Configure SAP Batch Release Hub business rules, release check suites, release decision triggers, and Quality Department authorization structures.
- Set up integration adapters through SAP Integration Suite and Cloud Platform Integration using public APIs and REST services.
- Establish integrations with SAP Global Batch Traceability or SAP S/4HANA batch genealogy to perform multi-tier genealogy checks.
- Manage extension development on SAP Business Technology Platform using Cloud Application Programming, RESTful Application Programming, Node.js, Java, or SAP Fiori and UI5 for customized release-check logic or localized compliance rules.
- Ensure technical implementations comply with Good Practice requirements, FDA 21 CFR Part 11, EU Annex 11, and European Medicines Agency guidelines.
- Configure secure electronic-signature workflows, audit logging, and data-freezing mechanisms upon release-decision confirmation.
- Prepare and execute Computer Software Validation deliverables, including Functional Specifications, Configuration Specifications, Installation/Operational/Performance Qualification protocols, and Traceability Matrices.
- Partner with Quality Assurance, Regulatory Affairs, and Qualified Persons to translate life sciences business requirements into functional Batch Release Hub features.
- Troubleshoot deployment issues on SAP Business Technology Platform subaccounts, Identity Authentication Service or identity-provider systems, and destination services.
- Work and lead independently to deliver complex enterprise resource planning solution designs and products that meet product requirements and business priorities.
- Identify product-level issues, propose solutions, apply continuous improvement, document and evolve architecture throughout the product life cycle, and drive adoption of new technologies.
- Determine methods and procedures for assignments and coordinate or guide team activities.
- Champion accountability by example, including taking technical lead or product owner roles, and help drive completion of major programs or product milestones.
- Solve complex problems, make independent product-level decisions, and report status at the product or product-line level.
- Communicate issues and potential solutions across product squads, project workstreams, and external stakeholder groups, and facilitate discussions.
- Provide technical oversight and guidance to product teams and improve existing solutions and business processes.
- Contribute to talent acquisition and capability development by screening résumés, interviewing candidates, mentoring, and organizing training.
- SAP Certified Development Associate certification for SAP Business Technology Platform.
- SAP Certified Integration Associate certification.
About the company
Roche is a global leader in pharmaceuticals and diagnostics. It develops medicines and diagnostic tools that help detect, monitor, and treat diseases, using research and biotechnology to drive new therapies and tests. Roche combines drug development with in-house diagnostic products to support personalized medicine, where treatments are tailored to individual patients based on test results. Its approach differs from many peers by integrating drug discovery with diagnostic capabilities and by expanding its research through strategic acquisitions (like Genentech) to strengthen its biotechnology and R&D capabilities. The company’s goal is to improve patient outcomes and healthcare worldwide by delivering reliable medicines, accurate diagnostic tests, and data-driven care.
Company Size
1-10
Company Stage
IPO
Headquarters
Basel, Switzerland
Founded
1896
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Simplify's Take
What believers are saying
- Enicepatide delivered 15.5% weight loss in September 2026 and 22.7% in June.
- pTau217 can scale immediately through Roche's existing lab network and improve Alzheimer diagnostics.
- Roche's June 2026 data and September 2026 filings signal multiple obesity shots on goal.
What critics are saying
- Eli Lilly and Novo Nordisk dominate obesity pricing, distribution, and physician mindshare today.
- Enicepatide remains Phase II-only; Roche starts late-stage glycemic and cardiovascular studies in 2027.
- If enicepatide disappoints, Roche burns its $2.7 billion Carmot bet and loses obesity credibility.
What makes Roche unique
- Roche combines pharma, diagnostics, and installed cobas labs across 4,500 U.S. instruments.
- Elecsys pTau217 won FDA clearance on August 24, 2026, and CE marking September 7.
- Roche controls obesity assets from Carmot and Zealand, spanning GLP-1/GIP and amylin.
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Benefits
Performance Bonus
Company News
The US Food and Drug Administration has approved Roche's Tecentriq in combination with a fluoropyrimidine and oxaliplatin for adjuvant treatment of stage III deficient DNA mismatch repair colon cancer. This marks Tecentriq's twelfth approved indication in the US. The approval follows the phase III ATOMIC study, published in The New England Journal of Medicine, which demonstrated that Tecentriq plus chemotherapy reduced the risk of disease recurrence or death by 50% compared to chemotherapy alone. The 36-month disease-free survival rate was 86% with the combination versus 76% with chemotherapy alone. Nearly 25% of colon cancers are diagnosed at stage III, and almost one in three stage III patients experience recurrence within five years. This represents the first approved adjuvant immunotherapy regimen for this patient population. Roche is pursuing further regulatory filings, including with the European Medicines Agency.
Roche posted strong Phase 2 results for its weight loss drug enicepatide, showing 22.5% mean weight loss over 48 weeks. This compares favourably to Eli Lilly's Zepbound, which achieved 20.2% weight loss over 72 weeks in a separate trial. In another Phase 2 study, enicepatide demonstrated HbA1c reductions of up to 2.65 percentage points in diabetic patients after 48 weeks, compared to tirzepatide's 2.37 percentage points after 52 weeks. Despite promising results, Roche faces stiff competition from Novo Nordisk and Eli Lilly, which both have deep pipelines in development. Novo Nordisk's CagriSema is nearing approval, whilst Eli Lilly's retatrutide has posted strong Phase 3 results. Roche's revenue grew 6% year over year in the first half of the year to 30.4 billion Swiss francs.
Roche has launched a newborn screening test that simultaneously detects three severe genetic conditions: Spinal Muscular Atrophy, Severe Combined Immunodeficiency Disease, and Sickle Cell Disease. TIB MOLBIOL, a Roche subsidiary, developed the LightMix Newborn TREC/SMN1/HBB kit for use in countries accepting the CE mark. The test enables early detection before symptoms appear, allowing clinicians to initiate life-changing treatments sooner. Early intervention can prevent severe nerve damage in SMA, enable lifesaving bone marrow transplants for SCID, and drastically lower infant mortality in SCD through preventive measures. The IVDR-approved test provides a ready-to-use solution that integrates into existing laboratory workflows. It runs on established LightCycler systems, making it accessible for private and academic hospital laboratories across Europe.
Roche's collaborator MediLink has announced positive phase III results for tambotatug pelitecan (Tam-Peli) in Chinese patients with relapsed small-cell lung cancer. The TAISHAN-302 trial showed Tam-Peli reduced the risk of death by 54% compared to topotecan, with median overall survival of 13.3 versus 9.4 months. The antibody-drug conjugate also demonstrated superior progression-free survival (7.4 versus 2.8 months) and objective response rates (59.1% versus 9.7%). China's National Medical Products Administration has accepted the New Drug Application for filing. Roche is developing and commercialising Tam-Peli outside mainland China, Hong Kong and Macau, with plans to rapidly initiate global trials. The therapy has received Breakthrough Therapy Designations from both the US FDA and China CDE for relapsed small-cell lung cancer.
Tempus AI has raised $600 million in Series C funding to scale its machine learning platform for cancer recurrence detection through liquid biopsies. The investment was led by SoftBank Vision Fund 2, with participation from Roche and Merck. Phase II trial data showed the AI-enhanced liquid biopsy analysis reduced false-negative results by 37% compared to conventional methods. The platform uses deep learning algorithms trained on over 12,000 genomic profiles to identify circulating tumour DNA fragments shed by residual cancer cells. A 2025 Nature Medicine study reported the system achieved 92% specificity in detecting minimal residual disease across breast, lung, and colorectal cancers. According to SEC filings, 45% of funds will support FDA pre-market approval trials, whilst 30% will fund global expansion into EU and APAC markets.