QA Manager - Quality & Compliance Leader (cGMP)

Amgen; Thousand Oaks (CA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Stock-based incentives

Retirement plan

Flexible work models

Job summary

Amgen is seeking a QA Manager in Thousand Oaks, CA, to oversee the quality assurance team, ensure products meet quality standards, and drive continuous improvements. You will coordinate audits, mentor staff, and collaborate with manufacturing, facilities, and engineering to maintain a culture of quality and compliance.

The role requires leadership experience, a strong background in cGMP, and the ability to interact with regulatory authorities during inspections.

Qualifications

• Must meet at least one degree requirement and have direct people management experience.
• Experience leading teams, projects, or resource allocation.
• Strong knowledge of cGMP, FDA/EMA regulations.

Responsibilities

• Oversee daily operations of QA team and ensure products meet quality standards.
• Coordinate audits and lead quality initiatives.
• Partner with manufacturing, supply chain, facilities, and engineering.
• Lead training programs on cGMP.
• Support internal and external audits and inspections.

Skills

Leadership

Quality management

cGMP compliance

Regulatory knowledge

Analytical thinking

Communication

Problem solving

Team management

Audit readiness

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Job description

Amgen is seeking a QA Manager in Thousand Oaks, CA, to oversee the quality assurance team, ensure products meet quality standards, and drive continuous improvements. You will coordinate audits, mentor staff, and collaborate with manufacturing, facilities, and engineering to maintain a culture of quality and compliance.

The role requires leadership experience, a strong background in cGMP, and the ability to interact with regulatory authorities during inspections.