Quality & Compliance
Manager, Vendor Quality
Office Location: Pasadena, CA or San Diego, CA or Verona, WI
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical 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 and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The purpose of this position within the Quality and Compliance department is to manage and oversee all aspects of Vendor Quality management activities. A key function of the position will involve continued development, oversight, maintenance, monitoring of the GCP, GLP, GCP, and cGMP (GxP) Vendor Quality. program and corporate policies at Arrowhead.
This position is part of the Quality Management Systems Center of Excellency will work closely with members of the Supply Chain, Legal, Quality, Purchasing, and Commercial teams to promote awareness of quality and regulatory compliance standards across GxP Vendors and ensure the GxP Vendors’ adherence to the relevant regulatory and contractual obligations.
Responsibilities
- Develop and optimize comprehensive vendor quality management program and processes that includes risk assessment, performance metrics, and continuous improvement
- Manage the development and maintenance of quality agreements with vendors to ensure clear expectations and compliance requirements are met; in collaboration with Legal and operational teams, negotiates quality agreements to align quality agreements with business goals and objectives
- Oversee GxP Vendor quality governance and compliance management by establishing, tracking, trending, and analyzing vendor quality metrics, quality key compliance indicators (QKPIs), and change management
- Prepare and present periodic reports and status of compliance to management, including the measures and activities to ensure compliance
- Support functional and corporate Quality Review Meetings to communicate any trends, issues, or risks related to vendor quality performance
- Lead investigations into vendor quality events (QEs) and supplier corrective actions requests (SCARS) thru engagement with cross-functional staff to ensure effective completion of required risk and impact assessments and implementation of corrective and preventive actions
- Lead and/or participates in process/quality improvement initiatives
- Support Quality Assurance vendor qualification program, including planning, participation, and follow-up of vendor audits
- Proactively drive culture of compliance by drafting and disseminating written materials and training that are aimed at increasing stakeholders’ awareness and understating of relevant regulatory requirements and industry standards
- Other duties as assigned
Requirements:
- BS and at least 5 years of relevant experience
- Strong knowledge of GCP/GLP/GvP/GMP, and relevant Federal, State, and international regulations, and the ability to determine phase appropriate requirements
- Competent knowledge of and ability to use Microsoft Office suite
- Ability to follow company procedures, work instructions, and policies
- Ability to process, synthesize and summarize complex issues
- Excellent judgment, and analytical, problem-solving skills
- Ability to work collaboratively across functions and with external partners
- Work in a safe manner; properly handle materials and chemicals
- Excellent attention to detail and organizational skills
- Ability to multi-task and prioritize work tasks with minimal supervision
- Excellent interpersonal, verbal, and written communication skills
Preferred:
- Advanced degree in relevant area
- Prior experience with use of an electronic document management system in a regulated environment
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.