Senior QA & Validation Leader - Facility Commissioning

Amgen; Holly Springs (NC); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Flexible work model

Generous time-off

Job summary

Amgen is seeking a Senior Manager of QA – Quality Validation & Technical Services to lead quality oversight for new facilities and equipment, ensuring cGMP compliance across design, installation, commissioning, qualification and process validation.

You will collaborate with Manufacturing, Facilities, Engineering and other functions to guide quality decisions, support audits, and drive continuous improvement while building a strong Quality team.

Qualifications

• Bachelor’s degree or higher plus relevant quality/operations experience.
• Minimum 2 years’ experience directly managing people or leading teams.
• Experience with cGMP regulations and quality systems.

Responsibilities

• Lead quality oversight for design, installation, commissioning, qualification, and process qualification of new facility and equipment.
• Provide leadership for quality review and approval of documents supporting commissioning and qualification.
• Ensure cGMP processes and quality systems compliance across activities.
• Collaborate cross-functionally to implement Quality Management System processes.
• Represent the Quality unit during audits and inspections.

Skills

Quality management

Leadership

Regulatory compliance

cGMP

Cross-functional collaboration

Problem solving

Education

High school diploma

Associate’s degree

Bachelor’s degree

Master’s degree

Doctorate degree

Tools

CAPA system

Quality document management

Job description

Amgen is seeking a Senior Manager of QA – Quality Validation & Technical Services to lead quality oversight for new facilities and equipment, ensuring cGMP compliance across design, installation, commissioning, qualification and process validation.

You will collaborate with Manufacturing, Facilities, Engineering and other functions to guide quality decisions, support audits, and drive continuous improvement while building a strong Quality team.