Senior Quality Assurance Manager

1 week ago


Verona, Mississippi, United States Arrowhead Pharmaceuticals Full time

Arrowhead Pharmaceuticals is a clinical stage biopharmaceutical company that develops medicines to treat intractable diseases by silencing the genes responsible for them. Our innovative RNAi-based therapeutics leverage the natural pathway of gene silencing to address conditions in virtually any therapeutic area.

Job Overview

The Senior Quality Assurance Manager will lead the quality leadership and oversight of medical device / drug combination products development and management at Arrowhead. This role requires strong knowledge of FDA regulations, ISO 13485, and other relevant international standards.

  • Serve as an internal subject matter expert in combinational products and primary lead for all relevant elements of QMS and quality aspects of combinational product development and management
  • Develop and maintain quality strategy and provide quality guidance to engineering team during all phases of design control, risk management, human factor engineering, process development, verification/validation testing, packaging, and distribution, as well as lifecycle management of design changes and documentation
Requirements

To be successful in this role, you will need:

  • BS or BA Degree in a relevant scientific or engineering discipline, and at least 8 years of relevant experience
  • Strong knowledge of FDA regulations (21 CFR Part 820, 21 CFR Parts 210/211), ISO 13485, and other relevant international standards
  • Experience leading QMS implementation, maintenance, and improvement initiatives, including CAPA, change control, and risk management processes

This role offers a competitive salary of $185,000 - $220,000 USD per year, plus excellent benefits. Arrowhead provides a safe and collaborative work environment with opportunities for professional growth and development.



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