Senior QA Manager, Biopharma | GxP & Audits

LeonaBio, Inc.; Bothell (WA); On-site; USD 80,000 - 120,000; Full time

Job summary

LeonaBio, Inc. in Bothell, Washington, is seeking a Quality Assurance Manager to enhance the quality assurance function within the organization. The role involves ensuring compliance with quality systems and leading QA support for outsourced cGMP operations.

The ideal candidate should have at least 5 years of experience in the pharmaceutical industry, a bachelor’s degree in a life science field, and strong leadership and analytical skills. This position offers a dynamic work environment with opportunities for travel.

Qualifications

• 5+ years of experience in the pharmaceutical industry.
• Working knowledge and understanding of GxPs for drugs in development.
• Experience with GCP, GCLP, GLP, and GMP audits is a plus.

Responsibilities

• Lead QA support for outsourced cGMP operations.
• Review executed batch records for compliance.
• Oversee product disposition activities.
• Support regulatory audits and inspections.

Skills

Analytical skills

Attention to detail

Leadership skills

Interpersonal skills

Organizational skills

Education

Bachelor’s degree in a life science field

Tools

Veeva

SharePoint

Job description

LeonaBio, Inc. in Bothell, Washington, is seeking a Quality Assurance Manager to enhance the quality assurance function within the organization. The role involves ensuring compliance with quality systems and leading QA support for outsourced cGMP operations.

The ideal candidate should have at least 5 years of experience in the pharmaceutical industry, a bachelor’s degree in a life science field, and strong leadership and analytical skills. This position offers a dynamic work environment with opportunities for travel.