What are the responsibilities and job description for the Clinical Quality Assurance, Specialist II position at Arrowhead Pharmaceuticals?
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
The Clinical Quality Assurance Specialist will participate in the activities in support of the GCP and the Quality Assurance departments at Arrowhead to ensure compliance with GCP standards. This includes support in investigator audit programs, risk management plans, regulatory inspections, generating metrics for continuous improvement, and quality events while collaborating cross-functionally to uphold clinical trial quality and regulatory compliance.
Key responsibilities include assisting in GCP Quality Event management (non-conformances, deviations, CAPAs), contributing to risk-based audit planning, support in audits and inspections, SOP review and collaborating closely with the Clinical Operations team to ensure GCP compliance and data integrity.
Responsibilities
- Develop and maintain clinical quality study risk plans and maintain updates in Quality Management System.
- Collect site metrics for selection of investigator site audits while analyzing and reporting trends in audit findings.
- Support and lead internal audits
- Support QMS (Veeva) Audit entry, dashboard
- SOP review
- Facilitate ongoing quality improvement through communication of audit results, CAPAs and other quality events.
- Issuance, tracking and completion of deviations, SCARs (supplier corrective action requests) and CAPAs.
- Provide support for clinical study programs with GCP compliance, as needed.
- Support health authority inspections.
- Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Serious Breaches).
- Keep up to date with all related quality legislation and compliance issues..
- Support and contribute to risk management analysis efforts associated with GxP functions (primarily GCP).
- Assist and/or support risk identification efforts at the asset / IP, therapeutic area, clinical study, clinical site, and vendor level.
- Identify KPIs involved with risk monitoring from internal and external sources.
- Communicate risk management mitigations and activities to the Manager Clinical Quality Assurance, Quality Assurance, and Clinical Operations and Development Teams.
Requirements
- Bachelor's degree in science discipline is required.
- 3 years of relevant experience in a regulated environment with preference to quality assurance, auditing and/or GCP experience.
- 2 years of relevant experience in GCP function providing Quality and Compliance oversight.
- Strong knowledge of GCP and Food & Drug Administration (FDA), European regulations and ICH guidelines.
- Competent knowledge of and ability to use Veeva, Microsoft Word, PowerPoint and Excel
- Requires occasional travel to other Arrowhead locations (San Diego, CA; Verona, WI; Pasadena, CA)
Preferred
- Prior experience with use of an electronic document management system in a regulated environment is preferred (Veeva)
- Knowledge of using Artificial Intelligence (AI) and/or building AI models (i.e., training dataset creation, validation, and reassessment) is beneficial.
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
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Salary : $80,000 - $95,000