Compliance Specialist
About the job
- Participate in multifunctional project teams as a Compliance representative, as directed by the Compliance Management Team.
- Compile, process, and facilitate the Annual Product Quality Review (APQR) in a timely manner.
- Review appropriate documentation and conduct internal audit activities, as directed by the Compliance Management Team, to help ensure adherence to regulatory requirements and industry guidance.
- Ensure the storage and archiving of documents comply with company policy and Regulatory Agency requirements.
- Assist with and coordinate compliance initiatives based on new regulations, guidance documents, and industry standards as they apply to site Quality Assurance.
- Participate in FDA readiness audits as required by the Compliance Management Team.
- Perform other duties as assigned by the Compliance Supervisor, Manager, or Director of Quality Assurance.
About the company
Fresenius Kabi provides medicines, medical devices, and related services to treat critically and chronically ill patients. Its portfolio includes biosimilars for autoimmune diseases and oncology, clinical nutrition products, infusion pumps and disposables, blood collection bags and devices, and IV fluids for infusion therapy. The company differentiates itself through leading positions in blood collection and infusion materials and by offering an integrated mix of pharma, nutrition, and MedTech under a single global platform. Its goal is to shape the future of healthcare by expanding leadership, improving patient care, and delivering sustainable value for stakeholders.
Company Size
10,001+
Company Stage
N/A
Total Funding
N/A
Headquarters
Bad Homburg, Germany
Founded
1999
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Simplify's Take
What believers are saying
- July 31, 2026 rituximab biosimilar approval broadens the autoimmune portfolio.
- September 29, 2026 transparent pricing can win payer access against PBM rebate games.
- October 1, 2026 mAbxience control improves biosimilar supply resilience and launch timing.
What critics are saying
- September 22, 2026 FDA warning letter cites CGMP failures at Melrose Park, Illinois.
- August 2026 recalls for Tyenne and morphine show repeated sterile-fill and labeling failures.
- The 2026 data breach and Haemonetics litigation threaten hospital trust and procurement losses.
What makes Fresenius Kabi unique
- September 29, 2026 Waltz Health deal puts three biosimilars directly before employers.
- October 1, 2026 mAbxience full ownership deepens Fresenius Kabi’s vertically integrated biosimilar pipeline.
- Fresenius Kabi combines injectable generics, prefilled syringes, and biosimilars across hospital channels.
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Benefits
401(k) Retirement Plan
Health Insurance
Dental Insurance
Vision Insurance
Wellness Program
Remote Work Options
Hybrid Work Options
Paid Vacation
Paid Holidays
Paid Sick Leave
Family Planning Benefits
Fertility Treatment Support
Stock Options
Disability Insurance
Life Insurance
Professional Development Budget
Conference Attendance Budget
Phone/Internet Stipend
Home Office Stipend
Mental Health Support
Hospice?
Company News
FDA issues warning letter to Fresenius Kabi over manufacturing violations in Illinois plant. Fresenius Kabi was accused by the U.S. Food and Drug Administration of failing to adequately investigate a critical manufacturing deviation linked to adverse events, according to an Oct. 1 report. The FDA inspectors spent three weeks earlier this year at the company's Melrose Park, Illinois, facility and identified concerns with how Fresenius Kabi responded to reports of adverse events in patients injected with famotidine, a medication used for heartburn and stomach ulcers. The FDA stated in a warning letter that the reports included apparent pyrogenic reactions, which can result in fever. Pyrogen contamination in injectable drugs can cause serious outcomes such as fever, hypotension, inflammatory reactions, anaphylactic shock or death. Inspectors found that famotidine injection manufacturing had exceeded multiple bioburden action limits. The agency said Fresenius Kabi "failed to sufficiently investigate this critical deviation and permitted batch release following passing finished drug product test results." Subsequent testing revealed an endotoxin failure and led to a recall of three batches. A spokesperson for Fresenius Kabi said no patient safety concerns have been identified so far, and that the facility remains operational without anticipated significant disruptions to supply. The spokesperson added that the company "is taking the necessary actions to address [the FDA's observations] thoroughly and responsibly." The FDA considered Fresenius Kabi's initial response inadequate after reviewing its reply in March to Form 483 findings. While acknowledging bioburden samples showed Gram-negative confluent growth - meaning bacteria covered the test medium - the company did not consider excessive bioburden as an elevated endotoxin risk, according to the agency. In addition, while Fresenius Kabi committed to improving endotoxin sampling and testing procedures, the FDA said it failed to promise a comprehensive review of its complaint system for increased vigilance. The agency emphasized ongoing robust upstream control is needed: "any batch testing that reveals atypical bioburden levels is a signal that necessitates prompt attention." The FDA also criticized how media fill failures were handled and noted incidents where hair was discovered as extrinsic contamination during visible particulate inspection starting May 2022. "Drug products contaminated with hair can have microbial contamination and are generally considered adulterated," stated the warning letter. Fresenius Kabi has been given 15 business days from Sept. 22 by the FDA to respond with corrective actions.
Fresenius Kabi manufacturing plant hit with FDA warning letter after adverse events. October 1, 2026 | Patients had adverse events after receiving a Fresenius Kabi medicine that experienced manufacturing deviations. The FDA has accused Fresenius Kabi of failing to sufficiently investigate a critical manufacturing deviation linked to reports of adverse events. FDA inspectors spent three weeks at Fresenius Kabi's manufacturing facility in Melrose Park, Illinois, earlier this year. The investigators found fault with Fresenius Kabi's response to reports of adverse events in patients injected with famotidine, an H2 blocker used to treat heartburn and stomach ulcers, the FDA explained in a warning letter published Tuesday. The reports included apparent pyrogenic reactions, a medical term for fever. Pyrogen contamination to injectable drug products can lead to significant adverse events such as fever, hypotension, inflammatory reactions, anaphylactic shock or death, the FDA told Fresenius Kabi. The company's famotidine injection manufacturing surpassed multiple bioburden action limits, the FDA said. The agency found Fresenius Kabi "failed to sufficiently investigate this critical deviation and permitted batch release following passing finished drug product test results." Subsequent testing in response to the adverse events revealed an endotoxin failure and triggered a recall of three famotidine batches. No patient safety concerns have been identified, a Fresenius Kabi spokesperson told BioSpace via email. The spokesperson said the facility "remains operational, and at this time we do not anticipate significant disruptions to the supply of products currently on the market," adding that the company "is taking the necessary actions to address [the FDA's observations] thoroughly and responsibly." The FDA deemed Fresenius Kabi's initial response inadequate. Replying in March to the FDA's Form 483, the company acknowledged that bioburden samples showed Gram-negative confluent growth, indicating that a lawn of bacteria covered the surface of the test medium. Fresenius Kabi did not consider the excessive bioburden, meaning the number of bacteria, an elevated endotoxin risk, the FDA said. Endotoxins are parts of bacteria that can activate the immune system, causing adverse events. While Fresenius Kabi vowed to enhance endotoxin sampling and testing, the FDA called out the company for failing to commit to a comprehensive review of its complaint system to increase vigilance. The FDA wants Fresenius Kabi to maintain ongoing, robust upstream control, adding that "any batch testing that reveals atypical bioburden levels is a signal that necessitates prompt attention." The FDA also criticized Fresenius Kabi's handling of media fill failures and the discovery of hair in drug products. Fresenius Kabi determined that operators' deficient aseptic techniques could have contributed to media fill failures. The company's investigations "did not consider how the poor aseptic practices went undetected by your firm's aseptic observer program during commercial operations," the FDA said. FDA inspectors found evidence that the compounding pharmacy was making versions of Eli Lilly's tirzepatide and Novo's semaglutide "regularly or in inordinate amounts" at a site with "insanitary conditions." September 24, 2026 Starting in May 2022, Fresenius Kabi documented at least nine cases of extrinsic contamination during its visible particulate inspection. The FDA named hair as an example of an extrinsic contaminant. "This contamination was described as free-floating and in direct contact with the drug product," the FDA said. "Drug products contaminated with hair can have microbial contamination and are generally considered adulterated. You did not initiate timely investigations in response to this contamination." The FDA, which sent the warning letter on Sept. 22, gave Fresenius Kabi 15 business days to respond. Remediations are underway at the site, the spokesperson said. Nick is a freelance writer who has been reporting on the global life sciences industry since 2008.
Fresenius completes acquisition of mAbxience, creating a stronger platform for future portfolio expansion. Oct 01, 2026, 01:00 ET * The transaction builds on the successful partnership between Fresenius and mAbxience established in 2022. * Full ownership creates a stronger platform to enhance quality and supply resilience, while supporting future innovation and broader patient access to high-quality biosimilars. * mAbxience will continue supporting its existing customers and remains fully committed to maintaining quality and reliable supply of its biosimilars. MADRID, Oct. 1, 2026 /PRNewswire/ - mAbxience today announced that Fresenius SE & Co. KGaA has acquired the remaining 45% of mAbxience from Insud Pharma, building on the successful partnership established between the two companies in 2022 and marking the beginning of a new phase of growth for the company. Fresenius acquired a 55% majority stake in mAbxience in August 2022 and has consolidated the business since then. Full ownership completes that structure: mAbxience biosimilars platform is now wholly owned within Fresenius Kabi's Biopharma business, which covers the full value chain from development and manufacturing through to commercialization. The acquisition builds on a successful partnership that has already delivered important development, manufacturing, technology-transfer and regulatory milestones. This collaboration has contributed to the expansion of manufacturing capabilities, the advancement of technology transfer programs and the strengthening of mAbxience's position as a global biopharmaceutical company. Bringing the organizations together under full ownership creates a stronger platform to enhance quality and supply resilience, while supporting future innovation and broader patient access to high-quality biosimilars at a time when a large wave of biologics is losing exclusivity. Michael Sen, Chief Executive Officer of Fresenius, said: "Completing the acquisition of mAbxience marks the next milestone in building a leading, vertically integrated biopharma business at scale. When we first invested in mAbxience four years ago, the market opportunity was promising but still evolving. Our initial majority stake gave us access to a highly competitive platform while managing risk. Since then, the market has developed strongly, mAbxience has delivered, and Fresenius now has the financial strength to take this next step. Full ownership gives us complete control over cost, capacity and launch timing, and full economic benefit, as the next wave of biologics loses exclusivity. For patients, that means dependable access to high-quality biosimilars; for shareholders, it is a disciplined investment in a business we know well." Jurgen van Broeck, Chief Executive Officer of mAbxience, said: "mAbxience was founded to serve patients, while proving that world-class biologics could be developed and manufactured at a cost the world could afford. Since 2022, our partnership with Fresenius has demonstrated the strength of combining our people, expertise and capabilities. I would also like to recognize and thank Insud Pharma for its support and commitment over the past decade. The success of mAbxience today is built on the vision, dedication and hard work of many people who have contributed to this journey from the very beginning. Full ownership is the natural next step and creates an even stronger platform for innovation, growth and long-term impact for patients, customers, and partners. As we begin this next chapter together, we will continue to build on the entrepreneurial spirit, scientific expertise and commitment to patients that have driven mAbxience's success." mAbxience will continue to support its existing customers and partners, and the company remains fully committed to maintaining quality, reliable supply and the delivery of its ongoing commitments worldwide. Jurgen Van Broeck, Chief Executive Officer of mAbxience, will continue to lead the business, reporting to Dr. Sang-Jin Pak, President Biopharma at Fresenius. SOURCE mAbxience
Does the direct-to-employer route for biosimilars make sense? Employers have strongly indicated that they would like to move away from the big 3 PBMs for cost transparency and the ability to capture as much of the savings as possible themselves. Going the direct-to-employer route, as Waltz Health and Fresenius Kabi are doing, would seem a natural option. Waltz Health, a digital health company, has announced that it has agreed to team with Fresenius Kabi to help supply its three biosimilars in a direct-to-employer arrangement through its existing Waltz Connect platform. First reported by Fierce Healthcare, the biosimilars that will be available direct-to-employer will be Fresenius Kabi's Idacio (adalimumab), Tyenne (tocilizumab), and Otufli (ustekinumab). Waltz Health already has direct-to-employer arrangements with Eli Lilly and Novo Nordisk for their GLP-1 products. By using Waltz Connect, corporate members can avoid traditional wholesaler and pharmacy benefit manager arrangements (and thus avoid rebate contracts). As the products are still delivered through specialty pharmacies, the typical provider and patient supports can still be provided. The direct-to-employer benefit for biosimilars. This channel would appear to assure that patients directly benefit from discounts received by the corporate employer. In Fierce Healthcare, Fresenius Kabi's President of Biopharma Sang-Jin Pak, MD, stated, "As we continue to expand our biosimilars portfolio, we remain focused on innovative partnerships that help employers and payers access high-quality treatment options." Employer benefit consultant F. Randy Vogenberg, PhD, told BR&R, "Making the costly drug purchase experience easier and engaging for the consumer as patient remains important. Leveraging biosimilar solutions could further the value to employers and their plan beneficiaries (patients) as other market forces change coverage affecting access to treatment options." Dr. Vogenberg, Principal, FRV Health Strategy Advisory, Greenville, SC, said, "Addressing economic coverage gaps can be a win-win short-term solution for multiple stakeholders." Assuming that the employers signing onto Waltz Health have access to the same pricing for biosimilars as PBMs and others do, this seems a natural option. In surveys, employers have strongly indicated that they would like to move away from the big 3 PBMs for cost transparency and the ability to capture as much of the savings as possible themselves. In other biosimilar news. Teva Pharmaceuticals received its second FDA approval for its denosumab biosimilar. After receiving its approval for Ponlimsi in March, referencing Prolia, to prevent osteoporosis, Degevma, referencing Xgeva, will be prescribed to prevent skeletal-related complications in patients with multiple myeloma or bone metastases. Teva plans to launch both products "in the coming months." It joins a crowded field of 9 manufacturers with both denosumab indications. Meitheal Pharmaceuticals announced September 28 that the FDA approved its high-concentration formulation of Yusimry, the company's adalimumab biosimilar. The company will now be able to compete for prescriptions for this most-used adalimumab biosimilar formulation. "With this approval, we now have FDA approval for both low- and high-concentration formulations of Yusimry, marking an important step in expanding treatment options for patients with certain chronic autoimmune diseases," said Tom Shea, Chief Executive Officer of Meitheal Pharmaceuticals. In July, the company had also received FDA approval for its insulin aspart biosimilar Garzulys, which is produced by Emerge Bioscience. Meitheal has marketing responsibility for this agent. This article was written by its Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry's original, comprehensive and updated database of biosimilar filings with the FDA.
Recalls, a data breach, and patent wars: inside Fresenius Kabi's mounting PR crisis. From a glass-particle biosimilar recall and a life-threatening labeling mix-up to a data breach and multiple patent lawsuits, Fresenius Kabi is facing a pileup of negative headlines that test its reputation management strategy. 2026-09-30 Subject: Fresenius Kabi Disclaimer: The information in this article was published by third parties and is aggregated here for research and commentary. All claims are attributed to their original sources. This is not legal advice. A company under pressure from every direction. Fresenius Kabi, the German pharmaceutical and infusion-therapy giant, is in the middle of a reputational gauntlet. In just the past few weeks, the company has issued two separate high-severity U.S. product recalls, is still absorbing fallout from a data breach disclosed earlier this year, and remains entangled in patent litigation with two major biotech rivals. Individually, each of these stories might be manageable. Together, they paint a picture of a company whose quality-control, cybersecurity, and legal defenses are being tested simultaneously - precisely the kind of multi-front crisis that erodes trust with regulators, clinicians, and patients alike. The most recent blow: glass particles in a biosimilar. The freshest headline, from just last week, is arguably the most damaging to Fresenius Kabi's clinical credibility. According to Fierce Pharma, the company launched a U.S. recall of a single lot of Tyenne - its biosimilar to Actemra (tocilizumab) - after glass particle contamination was discovered. Glass particulate in an injectable biologic is a serious manufacturing red flag; it raises questions not just about that one lot, but about quality assurance across the broader biosimilar production line. For a company positioning itself as a trusted low-cost alternative to branded biologics, contamination scares undercut the entire value proposition of biosimilars: that they're just as safe and reliable as the originator product. A labeling mix-up with life-or-death stakes. Just over a week before the Tyenne recall, Fresenius Kabi was forced into an even more alarming voluntary recall. Per Business Wire, the company recalled one lot of Morphine Sulfate Injection USP in a Simplist prefilled syringe after discovering that units labeled as morphine may have actually contained Dilaudid (hydromorphone). The company itself warned this mix-up carries a risk of life-threatening respiratory depression and death - about as severe a safety disclosure as a pharmaceutical manufacturer can make. Two separate high-severity recalls within a single month is a pattern regulators, hospital purchasing committees, and plaintiffs' attorneys will not ignore. This is exactly the scenario where proactive crisis-reputation-management matters more than a standard press release; the difference between a recall that fades from memory and one that becomes a recurring news hook often comes down to how transparently and quickly the narrative is controlled in the first 72 hours. Its crisis reputation management team specializes in exactly this kind of rapid-response containment. The data breach nobody wants to talk about. Compounding the safety narrative is a cybersecurity failure that predates the recalls but continues to cast a shadow. As reported by Claim Depot, Fresenius Kabi USA disclosed a data breach tied to its subsidiary Ivenix, exposing employee and customer Social Security numbers, medical records, and financial information. Health-data breaches are uniquely damaging because they combine regulatory exposure (HIPAA and state breach-notification laws) with the kind of consumer anger that fuels class-action recruitment and lingering search-engine visibility. Months later, breach notification sites and legal-referral pages referencing Sources. Disclaimer: The information presented in this article was published by third parties and is aggregated here for research and commentary purposes only. NegativePublicRelations.com does not claim these allegations as fact; all claims are attributed to their original publishers, linked above. Readers are encouraged to review the original sources. This post is not legal advice. "From a glass-particle biosimilar recall and a life-threatening labeling mix-up to a data breach and multiple patent lawsuits, Fresenius Kabi is facing a pileup of negative headlines that test its reputation management strategy." - NegativePublicRelations.com How NegativePublicRelations.com would respond. placeholder Original source This post is based on reporting by Fierce Pharma. NegativePublicRelations rewrite and analyze the story; the original article remains the property of its publisher. Facing a similar situation? Its reputation strategists can help. Reader feedback & talkbacks. Post anonymously - no registration required. Your name is optional. No feedback yet. Be the first to share your experience. Covert Dark PR Agency NegativePublicRelations is a Negative PR agency. Experts in hostile publicity, mass publishing of verified defamatory information, and damaging press directed at an individual or organization. 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