R

Roche

Global pharmaceuticals and diagnostics company

ERP Test Manager

Full-TimeUpdated on 10/21/2026
PLN19.1k - PLN35.4k+ Annual performance bonus + 20% target annual bonus
Expert
Poznań, Poland+1 moreMore locations: Warsaw, Poland
HybridTwo days in the office per week are currently required on average.
QA & Testing

About the job

Requirements
  • Extensive experience working in regulated environments such as life sciences, pharmaceuticals, or medical devices, with deep operational knowledge of GxP and Computer System Validation (CSV), and a track record of managing and defending testing processes during internal corporate quality audits and external regulatory inspections such as FDA or EMA inspections.
  • Extensive experience providing expert-level leadership and strategic guidance for high-impact software quality assurance projects, managing teams of quality engineers, establishing quality standards, and driving continuous improvement in testing strategies.
  • Deep technical expertise in SAP Solution Manager (SolMan), SAP Focused Build, or modern application lifecycle management tools such as Jira, Azure DevOps, or Micro Focus ALM/Quality Center, with proven experience in ERP implementation programs or projects and comprehensive understanding of testing frameworks and tools for enterprise ERP systems.
  • Expertise recommending quality assurance technologies and tools for business transformation, with advanced systems thinking and analytical reasoning to identify systemic quality issues, future risks, and strategic improvement opportunities.
  • Strong communication, negotiation, and matrix-management skills, demonstrated ability to navigate complex stakeholder networks, manage conflicts, drive executive consensus on quality standards, and challenge project deployment timelines when quality is at risk.
Responsibilities
  • Provide expert-level leadership and strategic guidance for high-impact or complex quality assurance projects; develop and implement Quality Engineering best practices across multiple initiatives, ensuring consistency, test traceability, and alignment with enterprise standards.
  • Lead quality analysis efforts on significant projects, guide less experienced Quality Engineers, contribute to strategic initiatives, and provide oversight and quality assurance to ensure testing purpose, scope, cohesion, traceability, and product value are aligned.
  • Own the master version of the ASPIRE Test Methodology and align process updates with CSV and Quality teams before rollout.
  • Author technical documentation, including standard operating procedures (SOPs), Work Instructions, and User Guides.
  • Lead analysis of complex and strategic software quality problems, define quality assurance scope, and drive root cause analysis for critical defects that may span organizational boundaries.
  • Elicit and analyze complex stakeholder quality needs, influence business stakeholders on product quality and release readiness, define strategic testing solution scope, manage complexity, and drive consensus on quality standards and release criteria.
  • Recommend quality assurance technologies and tools for business transformation and provide solutions to complex quality challenges.
  • Ensure all test phases, including SAT, UAT, and RT, start on time according to the global release calendar; track testing metrics, defect burn-down rates, and resource allocation to meet deadlines.
  • Author and present Test Summary Reports (TSR) to stakeholders, including a verdict on quality and go-live readiness.
  • Act as the lead subject matter expert for Testing during internal and external quality audits and ensure testing records are robust enough to withstand scrutiny.
  • Ensure GBPOs are aware of scope and provide timely Test Plan approvals.
  • Audit the ASPIRE lifecycle to identify friction points or missing controls, and design, pilot, and deploy testing workflows, templates, and frameworks to address gaps.
  • Evaluate SOPs and Work Instructions and streamline them while maintaining compliance.
  • Direct and mentor a small support team assisting with reporting and SolMan updates, and ensure programs and projects follow the overall test strategy.
  • Manage deviations from the ASPIRE methodology, ensuring each is risk-assessed, documented, and defensible.
  • Consult with project teams on complex testing requirements while maintaining delivery speed.

About the company

R

Roche

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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 Jobs

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

Yahoo Finance
Oct 16th, 2026
FDA approves Roche's Enspryng as first at-home injection for thyroid eye disease

Roche said the US Food and Drug Administration (FDA) has approved Enspryng (satralizumab) for adults with thyroid eye disease (TED). It is the first and only at-home subcutaneous treatment for the condition, and a patient or caregiver can administer it after training. In the Phase III SatraGO-2 trial, 52.9% of active TED patients on Enspryng had a proptosis (eye bulging) response, against 23.4% on placebo. Double vision fell in 60.7% of patients, against 25.8%. The SatraGO-1 trial missed its primary endpoint at Week 24. No new safety signals emerged. TED affects about 155 in every 100,000 people in the US. This is Enspryng's second approval, after neuromyelitis optica spectrum disorder in 2020. The FDA is also reviewing it for myelin oligodendrocyte glycoprotein antibody-associated disease, with a decision expected in January 2027.

Yahoo Finance
Oct 9th, 2026
FDA approves Roche's Tecentriq for stage III colon cancer, cutting recurrence risk by 50%

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.

Yahoo Finance
Sep 30th, 2026
Roche's enicepatide shows 22.5% weight loss in 48 weeks, challenging Eli Lilly and Novo Nordisk

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.

PR Newswire
Sep 30th, 2026
Roche launches newborn screening test for SMA, SCID and sickle cell disease

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.

Yahoo Finance
Sep 13th, 2026
Roche's Tam-Peli cuts death risk by 54% in Chinese SCLC trial, global phase III studies planned

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.