Senior Manager, Medical Device Quality​/Product Complaints

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein.

Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics.

Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

This position provides medical device and combination product quality assurance support at Arrowhead, with two areas of accountability: serving as the internal subject matter expert for medical device quality across the QMS and owning the product complaint management process for clinical and commercial combination products.

This position will report to the Director, Supplier Quality and works closely with members of Quality, Operations, Supply Chain, Regulatory, and Commercial teams, as well as external stakeholders and suppliers. This position will ensure clinical and commercial product quality remain in compliance with applicable US and international medical device regulations, standards and guidance.

This role is full-time onsite, 5 days a week in Verona, WI.

• Serve as an internal medical device SME, both US and ROW, for all relevant elements of QMS and quality of combination product development and commercialization, assuring proper integration and support of device regulations, including, but not limited to Change Management, Risk Management, DHF/DMR Maintenance, Internal Audits.
• Monitor, guide, and ensure internal stakeholders’ decision-making and actions are consistent with 21 CFR 820, 21 CFR 4, ISO 13485, ISO 14971, Good Distribution Practices (GDP), relevant international regulations and guidance, and Arrowhead policies and procedures.
• Develop, define, support, review, augment, and/or approve a variety of controlled documents to ensure adherence to Medical Device Regulations and requirements.
• Provide quality guidance to project teams throughout design control, risk management, human factors engineering, process development, verification and validation testing, packaging, and distribution, as well as lifecycle management of design changes and associated documentation
• Identify gaps in existing processes, as well as need for new processes. Collaborate with cross-functional teams to develop and implement solutions.
• Drive continuous improvement to the combination product QMS, monitoring and identifying areas for improvement.
• Review Clinical Study Plans that include device…