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Roche

Global pharmaceuticals and diagnostics company

Principal Commissioning & Qualification Manager

Full-Time
No salary listed
Senior
Bachelor's, Master's
Penzberg, Germany+1 moreMore locations: Mannheim, Germany
In PersonLocally based in Mannheim or Penzberg; travel up to 20%, with potential deployment across future EU project locations.
Biology & BiotechRegulatory & Quality (Life Sciences)

About the job

Requirements
  • A bachelor's degree with 6–8 years of relevant experience, a master's degree with 5–7 years of relevant experience, or equivalent professional background within the pharmaceutical industry.
  • Strong hands-on experience in Commissioning, Qualification, and Validation (CQV) for systems and equipment, including sterile drug manufacturing, warehousing, utilities, and automation.
  • Proven understanding of risk-based commissioning and qualification strategies, such as ASTM E2500, and global regulatory standards, including FDA, EMA, and ICH.
  • A proven track record applying modern project management tools, problem-solving, and driving change while balancing project risks.
  • Excellent written and spoken English and German skills, with the ability to work across diverse cultural environments and organizational levels.
  • Flexibility and readiness to lead directly on-site, travel up to 20%, and remain hands-on during active design or construction phases.
Responsibilities
  • Lead and manage business-critical commissioning and qualification sub-projects with large local or international scope supporting Good Manufacturing Practice manufacturing operations, affiliates, and contract manufacturing organizations.
  • Develop, align, and drive commissioning and qualification project schedules and resource plans to support timely, budget-compliant delivery.
  • Assign tasks according to team members’ strengths, provide technical guidance to mid-sized project teams, and foster collaboration.
  • Communicate project status to stakeholders, provide proactive advice, and maintain information flow across cross-functional teams and external contractors.
  • Ensure project strategies and deliverables comply with global regulatory requirements, industry standards, and quality management systems.
  • Serve as Sub-Project Manager for Commissioning & Qualification within Global Engineering and as the first-line technical expert across the full project lifecycle.
  • Own project schedule, scope, and budget to deliver target functionality, regulatory compliance, and operational excellence.
  • Partner with project management, manufacturing operations, quality teams, site leadership, and external service providers to translate global regulatory requirements and operational needs into practical solutions.

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

PR Newswire
Nov 2nd, 2026
Roche wins FDA clearance for respiratory panel detecting up to 19 pathogens in under two hours

Roche has received US Food and Drug Administration (FDA) 510(k) clearance for its cobas eplex respiratory pathogen panel 3 (RP3), the company announced on November 2, 2026. The test detects up to 19 viruses and bacteria from a single nasopharyngeal swab. It adds Bordetella pertussis and updates its assays for influenza A and SARS-CoV-2 to cover more strains. Laboratories can choose from up to five panel configurations to match local disease prevalence and patient needs. The test needs less than one minute of hands-on time and returns results in under two hours. It runs on the automated cobas eplex system and expands on the RP2 panel, which is authorised for emergency use.

Yahoo Finance
Oct 29th, 2026
HER2 targeted therapies market to hit $16.34B by 2030 on 8.6% CAGR

The global HER2 targeted therapies market is forecast to grow from $10.84 billion in 2025 to $11.75 billion in 2026, according to a Research and Markets report. It is expected to reach $16.34 billion by 2030, a compound annual growth rate (CAGR) of 8.6% from 2026. Demand for targeted cancer treatments, rising breast and gastric cancer rates, and wider use of monoclonal antibody therapies are driving growth. Precision oncology, broader biomarker testing, and next-generation antibody-drug conjugates should support it further. In February 2026, Boehringer Ingelheim won US Food and Drug Administration approval for HERNEXEOS (zongertinib) for HER2-mutant advanced non-small cell lung cancer. In December 2023, Pfizer bought Seagen for about $43 billion. North America led the market in 2025; Asia-Pacific is expected to grow fastest.

Yahoo Finance
Oct 28th, 2026
Roche launches BAP1 test to distinguish mesothelioma from other cancers

Roche has launched the VENTANA BAP1 (SP527) test worldwide to help diagnose mesothelioma, a rare and deadly cancer. The automated immunohistochemistry assay helps pathologists tell mesothelioma apart from other cancers, including non-small cell lung cancer, and from benign tissue growth. The test is registered as a Class I IVD with the US Food and Drug Administration and has IVDR approval as a Class C device. Roche announced the launch in Basel on October 28, 2026. Most patients are diagnosed late, with median overall survival of just 12 to 18 months. BAP1 works alongside the recently launched MTAP and Claudin-4 tests, which help preserve limited tissue samples for molecular sequencing. "Timely differential diagnosis of mesothelioma is critical to help deliver the best outcome for patients," said Matt Sause, chief executive officer of Roche Diagnostics.

Yahoo Finance
Oct 27th, 2026
Zymeworks signs Roche deal worth up to $718M in milestones, shows 65% response in ovarian cancer

Zymeworks has agreed a collaboration with Roche on ZW209, a T-cell engager that targets DLL3-positive tumours, including small cell lung cancer. The deal is subject to Hart-Scott-Rodino Act clearance. Zymeworks would receive $55 million upfront and $40 million when a Phase 1b study begins. It could also earn up to $718 million in milestones, plus tiered royalties from high single digits to mid-teens. Roche would fund research and development, and take over later development and commercialisation. Zymeworks will run the first global trial. Zymeworks also reported updated data for ZW191 in platinum-resistant ovarian cancer. In high-grade serous disease, confirmed response rates were 65% at 6.4 mg/kg and 55% at 9.6 mg/kg. The company is seeking partners to fund further development.

Yahoo Finance
Oct 27th, 2026
Roche wins CE Mark for compact cobas smart e immunoanalyser with 100+ planned assays

Roche has received the CE Mark for its cobas smart e immunoanalyser, a compact testing platform for smaller hospitals and laboratories. The company announced the approval in Basel on October 27, 2026. The device fits in a footprint of under one square metre and has a planned menu of over 100 assays. Reaction times are 18 minutes or less for more than 90% of Roche immunoassays, which can help local facilities cut turnaround times. It uses the same reagents and Elecsys technology as Roche's high-throughput systems, so results stay consistent across sites. Roche says it needs one minute of daily operator input and cuts hands-on maintenance by up to two-thirds compared with earlier platforms. It joins the cobas e 402 and cobas e 801 units, completing a range for clinics through to large hospital laboratories.