Senior QA Leader, Quality Validation & Technical Services

Amgen SA; Holly Springs (NC); On-site; USD 140,000 - 190,000; Full time

Job summary

Amgen is seeking a Senior Manager QA – Quality Validation & Technical Services to lead quality oversight of design, installation, commissioning and qualification for a new facility and equipment. You will collaborate with Manufacturing, Facilities & Engineering and other support functions to ensure project timelines and compliance.

You will provide coaching on cGMP processes, oversee documentation and records, and drive continuous improvement while building a strong QA team for current and

Qualifications

• High school diploma or GED with 12+ years in Quality/Operations.
• Associate’s degree with 10+ years in Quality/Operations.
• Bachelor’s degree with 8+ years in Quality/Operations.
• Master’s degree with 6+ years in Quality/Operations.
• Doctorate degree with 2+ years in Quality/Operations and 2+ years of people leadership.

Responsibilities

• Lead quality oversight for design, installation, commissioning & qualification and process qualification of the new facility and equipment.
• Collaborate cross-functionally across construction, start-up, and operations to meet timelines.
• Provide quality guidance on cGMP processes, documents, records, and quality systems.
• Ensure facilities/equipment comply with cGMP and applicable regulations.
• Build and manage a team of Quality professionals and lead QA leadership for current and future facilities.
• Represent the quality unit during audits and inspections as needed.

Skills

Quality leadership

Cross-functional collaboration

Regulatory awareness

Communication (verbal & written)

People management

Education

Bachelor’s degree

Master’s degree

Doctorate degree

Job description

Amgen is seeking a Senior Manager QA – Quality Validation & Technical Services to lead quality oversight of design, installation, commissioning and qualification for a new facility and equipment. You will collaborate with Manufacturing, Facilities & Engineering and other support functions to ensure project timelines and compliance.

You will provide coaching on cGMP processes, oversee documentation and records, and drive continuous improvement while building a strong QA team for current and