Senior QA Manager, PQA – Biotech Manufacturing

Amgen Inc.; Holly Springs (NC); On-site; USD 118,000 - 160,000; Full time

Benefits offered by this job

Retirement plan

Medical/Dental/Vision

Life and disability insurance

Flexible spending accounts

Annual bonus program

Stock-based incentives

Generous time-off

Job summary

Amgen Inc. is seeking a Manager Quality Assurance – PQA to lead the Plant Quality Assurance team for ANC startup activities and ongoing 24/7 support. You will oversee quality documents, validation tasks, and change control while ensuring compliance with cGMP and GDP.

You will manage staff, drive process improvements, and participate in inspection readiness, partnering with diverse teams to meet safety and quality goals across manufacturing operations.

Qualifications

• High school diploma / GED with 12 years quality experience.
• Associate’s degree with 10 years quality experience.
• Bachelor’s degree with 5 years quality experience.
• Master’s degree with 3 years quality experience.
• Doctorate degree.

Responsibilities

• Staff for the PQA team are on-site workers and support 24/7 operations.
• Oversee startup activities for facilities, equipment, and systems and ensure alignment with quality systems.
• Lead a team of PQA staff, manage schedules, and provide ongoing quality oversight.
• Develop and communicate procedures and standards for operations and quality.
• Support site audits, inspections, and incident triage as needed.

Skills

People management

Leadership

Quality assurance

Communication

Project management

Team collaboration

Education

Bachelor degree

Master degree

Doctorate

Associate degree

Tools

CDOCS

Trackwise

Maximo

LIMS

MES Werum

Job description

Amgen Inc. is seeking a Manager Quality Assurance – PQA to lead the Plant Quality Assurance team for ANC startup activities and ongoing 24/7 support. You will oversee quality documents, validation tasks, and change control while ensuring compliance with cGMP and GDP.

You will manage staff, drive process improvements, and participate in inspection readiness, partnering with diverse teams to meet safety and quality goals across manufacturing operations.