Full-Time
Senior Manager
Quality Management System Programs
Posted on 8/29/2025
Arrowhead Pharmaceuticals
501-1,000 employees
Develops RNAi-based gene-silencing therapies
Compensation Overview
$130k - $150k/yr
Fitchburg, WI, USA
In Person
 Biology & Biotech (4) |
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- Bachelor's degree in life sciences, pharmacy, chemistry, or related field.
- 8 years of experience in the regulated pharmaceutical and/or biotechnology industry, in which at least five (5) of those years were in a leadership position with increasing levels of responsibility.
- Full knowledge of GxP regulations, including GMP (FDA, EU, etc.), ICH guidelines, and ISO standards.
- Demonstrated skills in the areas of project management, organization, and execution as well as priority setting.
- Proven experience developing and/or improving QMS, QE, and compliance programs.
- Highly motivated, strategic thinker with a focus on continuous improvement and innovation, who endeavors to anticipate and resolve problems.
- Excellent communication, interpersonal, and leadership skills, with the ability to work with a diverse range of professionals and influence stakeholders at all levels.
- Previous experience with the use of electronic document / quality management systems (EMDS / EQMS).
- Ability for occasional business travel.
- Coordinate and facilitate stakeholder involvement as systems are continuously monitored and improved to augment compliance and increase efficiencies.
- Identify, champion, and drive improvements to streamline and upgrade the QMS processes in the following areas: Document Control & Training: EDMS/EQMS, document lifecycle management, training program design and administration; Conformance & Continuous Improvement: deviation and OOS investigations, product complaint management, product recall, CAPA, internal auditing; Change & Risk Management: design of change and risk management framework and application of methodologies; Quality Engineering: asset lifecycle management; facility, utility, and equipment commissioning, qualification, validation (CQV); process validation lifecycle and annual product reviews; cleaning validation and environmental monitoring; computer system validation and assurance.
- Develop, define, support, review, augment, and/or approve a variety of controlled documents, including quality system and technical documents.
- Lead the QMS team in the application of project management and project execution methodologies with a focus on prioritization and resource management.
- Support the QMS team with the development of registers, schedules, metrics, and dashboards as well as mechanisms for tracking and reporting.
- Maintain project plans and project metrics and ensure visibility within the QMS team and to stakeholders.
- Foster a culture of quality, collaboration, and accountability within the team and across the organization.
- Perform additional duties as requested.
- Advanced degree in life science.
Arrowhead Pharmaceuticals develops medicines using RNA interference (RNAi) to silence disease-causing genes. The company’s approach uses a library of RNA chemistries and delivery methods to trigger RNAi, enabling rapid and durable reduction of target gene expression in cells. This gene-silencing strategy aims to treat severe genetic diseases such as cystic fibrosis and hepatitis B by lowering disease-related proteins. Arrowhead’s products are advanced through discovery and development partnerships, licensing deals, and potential commercialization of approved therapies. The company differentiates itself through a broad RNAi platform, proprietary delivery tech, and collaborations with larger pharma firms to advance its pipeline. Its goal is to provide new treatment options for conditions with limited or no effective therapies by translating gene silencing into medicines that can halt or reverse disease progression.
Company Size
501-1,000
Company Stage
IPO
Headquarters
Pasadena, California
Founded
2004
Simplify's Take
What believers are saying
- REDEMPLO FDA approval drove $264M FQ1 2026 revenue and $30.8M profit from milestones.
- $1B Madrigal deal for ARO-PNPLA3 provides $25M upfront plus milestones and royalties.
- Breakthrough Therapy for plozasiran expands REDEMPLO to severe hypertriglyceridemia market.
What critics are saying
- Madrigal out-licensing ARO-PNPLA3 eliminates internal MASH revenue by 2027.
- Wave Life Sciences INHBE data erodes Arrowhead obesity program value in 2026.
- Novartis and Sarepta withhold milestones if ARO-DIMER-PA fails Phase 1/2a in 2027.
What makes Arrowhead Pharmaceuticals unique
- TRiM platform enables tissue-agnostic RNAi delivery across liver, pulmonary, and cardiometabolic diseases.
- Pioneers dual-function siRNA like ARO-DIMER-PA targeting two genes in one molecule.
- Targets undruggable genes via proprietary RNA chemistries for rapid, durable knockdown.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
401(k) Retirement Plan
Paid Vacation
Paid Sick Leave
Company News
Arrowhead Pharmaceuticals has raised $264 million in revenue for FQ1 2026, transitioning to a commercial-stage company following FDA approval of REDEMPLO (plozasiran), its first medicine for treating familial chylomicronemia syndrome. The drug also received regulatory clearance in China and Canada, with over 100 initial prescriptions in the US. The company swung to a net income of $30.8 million, compared to a $173.1 million loss in the prior year period. Revenue was boosted by a $200 million upfront payment from a collaboration with Novartis and a $200 million milestone from Sarepta Therapeutics. Arrowhead also initiated a Phase 1/2a trial for ARO-DIMER-PA, the industry's first dual-function clinical candidate targeting two genes in one molecule.
Vanscoy Rare Pharmacy selected as exclusive specialty pharmacy provider for Redemplo. Vanscoy Rare Pharmacy, a leading specialty pharmacy focused on supporting people living with rare conditions, announced that it has been selected as the exclusive specialty pharmacy provider for Arrowhead Pharmaceuticals' Redemplo (plozasiran), a small interfering RNA (siRNA) medicine, indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). FCS is a severe, rare disease, with an estimated 6,500 people in the U.S. living with genetic or clinical FCS, characterized by triglyceride levels that can be 10 to 100 times higher than normal leading to a substantially higher risk of developing acute, recurrent, and potentially fatal pancreatitis. With the FDA approval of Redemplo, patients will have access to a targeted treatment option designed to address the underlying cause of FCS. Through this agreement, Vanscoy Rare Pharmacy will provide patients with comprehensive support at each stage of their treatment journey with Redemplo. Arrowhead launched REDEMPLO independently in the U.S. with the OneREDEMPLO pricing model that creates one consistent price across current and potential future indications. Arrowhead is targeting approximately 5,000 healthcare professionals through personal promotion, complemented by a much broader omnichannel effort. REDEMPLO was recently approved by Health Canada's approval of REDEMPLO as a new treatment option for Canadians living with genetic or clinical FCS, giving patients, providers, and caregivers alike a convenient dosing option that can be self-administered at home with a subcutaneous injection once every three months. Pending regulatory review and approval, Arrowhead expects to potentially launch REDEMPLO later this year in select EU countries and in the UK. In Greater China, REDEMPLO will be marketed by Sanofi. #Redemplo #ArrowheadPharmaceuticals #FCS #VanscoyRarePharmacy #OneRedemplo #exclsuivespecialtypharmacy
RNS Number : 6001T Silence Therapeutics PLC 09 January 2017 Acquisition of minority stake in Arrowhead Pharmaceuticals 9th January 2017 London, 9th January 2017 - Silence Therapeutics plc, AIM:SLN ("Silence" or the "Company") a leader in the discovery, delivery and development of novel RNA therapeutics for the treatment of serious diseases with unmet medical need, announces that it has acquired a stake, on-market, in Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) ("Arrowhead") of 6,006,359 common shares, representing 8.4% of the common share capital of Arrowhead, for a total cash consideration of $9.6 million (£7.8 million(1)), excluding transaction costs. Since the capital raise of May 2015, Silence has been actively evaluating a number of RNAi assets, including technologies within both listed and unlisted RNAi companies. Arrowhead is a US based NASDAQ listed company that develops medicines to treat intractable diseases by silencing the genes that cause them by means of a broad
PASADENA, Calif.–(BUSINESS WIRE)– Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it closed a previously announced private offering with a select group of investors including Orbimed, RA Capital Management, Perceptive Advisors, RTW Investments and certain other institutional investors. Gross proceeds were $45 million. Approximately 7.63 million shares of common stock were issued at a price […]
Bernstein raises Arrowhead pharma stock price target to $35 on obesity data. Investing.com - Bernstein SocGen Group has raised the price target on Arrowhead Pharmaceuticals (NASDAQ:ARWR) to $35.00 from $17.00 while maintaining a Market Perform rating ahead of the company's upcoming obesity data update. The new target sits at the low end of analyst projections, which range from $35 to $100, according to InvestingPro data. Currently trading at $66.39, ARWR appears overvalued based on InvestingPro's Fair Value assessment. The price target adjustment reflects increases to Bernstein's severe hypertriglyceridemia (SHTG) estimates and the addition of obesity treatment potential to their valuation model. The new target represents the average of a discounted cash flow analysis to 2035 and an enterprise value to revenue multiple of 1.75x 2035 revenue. This valuation approach aligns with ARWR's current high multiples, with InvestingPro data showing an EV/EBITDA of 72.58 and a Price/Book ratio of 19.36. Bernstein noted that Arrowhead is among several companies pursuing non-incretin mechanisms to treat obesity, with the aim of reducing fat while preserving muscle. Other companies in this space include Eli Lilly, Roche, Regeneron, Scholar Rock, Wave Life Sciences, Alnylam, and Biohaven. Despite not being profitable over the last twelve months, ARWR maintains a strong financial health score of "GREAT" according to InvestingPro's comprehensive analysis, with liquid assets exceeding short-term obligations. The analyst highlighted recent data from Wave Life Sciences suggesting that INHBE, which Arrowhead is also pursuing, may be a better target than myostatin. This disclosure on December 8 generated substantial investor excitement, with Wave shares rising 150% and Arrowhead gaining 12%. Despite the price target increase, Bernstein recommends staying on the sidelines for Arrowhead's upcoming data update, suggesting approximately 20% potential movement in either direction. The firm believes shares are already pricing in substantial optimism, estimating $10-15 of obesity treatment value in the current stock price. In other recent news, Arrowhead Pharmaceuticals has launched Redemplo for Familial Chylomicronemia Syndrome, with Piper Sandler forecasting significant U.S. sales by 2026. The firm raised its price target for Arrowhead to $100, noting Redemplo's superior attributes compared to other treatments. RBC Capital also increased its price target for Arrowhead to $80, citing positive developments and early commercial traction for Redemplo, as well as optimism about upcoming trial results for the company's severe hypertriglyceridemia candidate. H.C. Wainwright set its price target at $85, praising the recently approved Redemplo label for its safety and convenience. Additionally, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to Arrowhead's investigational drug plozasiran for severe hypertriglyceridemia. Arrowhead has also dosed the first subjects in a Phase 1/2a clinical trial for ARO-MAPT, targeting tauopathies such as Alzheimer's disease. This trial utilizes a new delivery system designed to cross the blood-brain barrier, showing potential in preclinical studies. This article was generated with the support of AI and reviewed by an editor. For more information see our T&C. Should you be buying ARWR right now? ProPicks AI evaluates ARWR alongside thousands of other companies every month using 100+ financial metrics. Using powerful AI to generate exciting stock ideas, it looks beyond popularity to assess fundamentals, momentum, and valuation. The AI has no bias - it simply identifies which stocks offer the best risk-reward based on current data with notable past winners that include Super Micro Computer (+185%) and AppLovin (+157%). Want to know if ARWR is currently featured in any ProPicks AI strategies, or if there are better opportunities in the same space?