Senior Quality Leader – QA, Validation & Tech Services

Amgen Inc. (IR); Holly Springs (NC); On-site; USD 144,000 - 195,000; Full time

Benefits offered by this job

Total Rewards Plan

Competitive benefits

Discretionary bonus

Job summary

Amgen NC seeks a SR MANAGER QA – QUALITY VALIDATION & TECHNICAL SERVICES to lead quality oversight of the design, installation, commissioning and qualification of the new facility and equipment, ensuring alignment with cGMP and Amgen standards.

You will partner with Manufacturing, Facilities & Engineering and other support functions to meet project timelines, provide quality guidance, coach a growing team of professionals, and drive continuous improvement across current and future facilities.

Qualifications

• Bachelor’s degree and 8+ years QA/Operations experience.
• 2+ years of people management/leadership experience.
• Strong knowledge of cGMP, quality systems and regulatory trends.

Responsibilities

• Lead quality oversight of design, installation, commissioning, qualification, and process qualification for new facilities.
• Collaborate with Manufacturing, Facilities & Engineering and support functions to ensure compliance.
• Provide coaching and direction on cGMP processes, docs, records, and change controls.

Skills

People management

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor’s degree + 8+ years QA/Operations experience

Job description

Amgen NC seeks a SR MANAGER QA – QUALITY VALIDATION & TECHNICAL SERVICES to lead quality oversight of the design, installation, commissioning and qualification of the new facility and equipment, ensuring alignment with cGMP and Amgen standards.

You will partner with Manufacturing, Facilities & Engineering and other support functions to meet project timelines, provide quality guidance, coach a growing team of professionals, and drive continuous improvement across current and future facilities.