GxP Quality Systems Manager

Ionis Pharmaceuticals, Inc.; Carlsbad (CA); Presencial; USD 70 844 - 102 371; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Benefits package

Resumo da oferta

Ionis Pharmaceuticals, Inc. in Carlsbad, CA, is seeking a Manager/QA Associate, GxP Quality Systems, to oversee GMP and GxP QA activities and ensure regulatory alignment.

You will support QMS workflows, data analysis, and cross-functional inspections readiness, while driving continuous improvement across Ionis quality systems. The role requires a Bachelor’s degree in a science-related field and 3+ years in QA/QMS with GxP familiarity; AI tools experience is a plus.

Qualificações

• Bachelor’s degree in a science-related field required.
• 3+ years of QA/QMS experience in a regulated environment.
• Familiarity with GxP quality systems and regulatory expectations.
• Strong written and verbal communication skills.

Responsabilidades

• Support QMS processes to ensure GMP/GxP alignment with regulations.
• Generate and trend QMS metrics; identify risks and improvement opportunities.
• Lead cross-functional initiatives to strengthen QA compliance and inspection readiness.
• Support Quality Management Review activities and audit responses.
• Coordinate vendor management and supplier audits.
• Contribute to new quality initiatives and company-wide projects.
• Help implement corporate quality and continuous improvement programs.

Conhecimentos

QA experience

Regulatory knowledge

GxP familiarity

Communication skills

Formação académica

Bachelor’s degree in a science-related field

Descrição da oferta de emprego

Ionis Pharmaceuticals, Inc. in Carlsbad, CA, is seeking a Manager/QA Associate, GxP Quality Systems, to oversee GMP and GxP QA activities and ensure regulatory alignment.

You will support QMS workflows, data analysis, and cross-functional inspections readiness, while driving continuous improvement across Ionis quality systems. The role requires a Bachelor’s degree in a science-related field and 3+ years in QA/QMS with GxP familiarity; AI tools experience is a plus.