Senior QA Lead: Quality Validation & Technical Services

Regulatory Jobs; Holly Springs (NC); On-site; USD 144,000 - 195,000; Full time

Job summary

Amgen is seeking a SR Manager QA – Quality Validation & Technical Services to lead the quality oversight of facility design, qualification, and validation efforts for a new plant and equipment. You will partner across Manufacturing, Facilities, Engineering, and QA to ensure cGMP compliance and timely project milestones.

The role requires strong leadership, regulatory knowledge, and the ability to drive continuous improvement in quality systems, documentation, and risk-based decision making in a

Qualifications

• Bachelor’s degree in science/engineering with QA exposure.
• Experience leading quality teams and cross-functional projects.
• Strong knowledge of cGMP, regulatory trends, and quality systems.

Responsibilities

• Lead quality oversight of design, installation, commissioning and qualification.
• Collaborate with Manufacturing, Facilities & Engineering and others.
• Provide coaching on cGMP processes, documents, records and QC systems.
• Direct quality review and approval of documents for commissioning timelines.
• Represent the quality unit during audits and inspections.

Skills

Leadership

Regulatory knowledge

Quality systems

Communication skills

Risk-based decisions

Education

Bachelor's degree in science/engineering

Master’s degree

Doctorate degree

Job description

Amgen is seeking a SR Manager QA – Quality Validation & Technical Services to lead the quality oversight of facility design, qualification, and validation efforts for a new plant and equipment. You will partner across Manufacturing, Facilities, Engineering, and QA to ensure cGMP compliance and timely project milestones.

The role requires strong leadership, regulatory knowledge, and the ability to drive continuous improvement in quality systems, documentation, and risk-based decision making in a