Night Shift QA Manager: Lead, GMP & Audits

BioSpace; West Greenwich (RI); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Flexible work models

Career development opportunities

Job summary

Amgen is seeking a Manager QA - Nights to lead and develop Quality Assurance professionals on the night shift, ensuring compliance with GMP manufacturing practices. You will hire, train, and manage teams, oversee investigations, and ensure timely change control and continuous improvement initiatives.

The role requires strong leadership, deep QA knowledge, and the ability to coordinate with cross-functional partners to sustain product quality and manufacturing excellence.

Qualifications

• Directly managing people and teams with leadership responsibilities.
• Experience in quality or manufacturing environments.
• Knowledge of GMP manufacturing and change control processes.
• Familiarity with investigations, CAPA and product release procedures.

Responsibilities

• Oversee night shift Quality Assurance teams and align with GMP expectations.
• Lead investigations and drive root-cause analyses for quality events.
• Review/approve manufacturing procedures, validation protocols, and change controls.
• Partner with management to allocate resources and drive continuous improvement.

Skills

People management

Leadership

Decision making

Communication

Education

Doctorate degree

Masters degree

Bachelor's degree

Associates degree

High school diploma / GED

Job description

Amgen is seeking a Manager QA - Nights to lead and develop Quality Assurance professionals on the night shift, ensuring compliance with GMP manufacturing practices. You will hire, train, and manage teams, oversee investigations, and ensure timely change control and continuous improvement initiatives.

The role requires strong leadership, deep QA knowledge, and the ability to coordinate with cross-functional partners to sustain product quality and manufacturing excellence.