QA & Validation Leader - Facility Quality & Compliance

Amgen Inc. (IR); Holly Springs, Northern (NC, KY); Hybrid; USD 144,000 - 195,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Flexible work models

Time-off plans

Job summary

Amgen Inc. is seeking a Sr Manager QA – Quality Validation & Technical Services to lead quality oversight for the design, installation, commissioning and qualification of a new facility and equipment.

You will partner with Manufacturing, Facilities & Engineering to ensure project milestones and regulatory requirements are met. The role requires seasoned QA leadership, strong knowledge of cGMP, and the ability to influence cross-functional teams.

Qualifications

• High school diploma/GED with 12 years Quality and/or Operations experience or Associate’s degree with 10 years, or Bachelor’s degree with 8 years, or Master’s with 6 years, or Doctorate with 2 years in Quality/Operations.
• Minimum of 2 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing resource allocation.

Responsibilities

• Lead quality oversight of design, installation, commissioning & qualification and process qualification for the new facility and equipment.
• Provide quality guidance to strategic and tactical decisions ensuring regulatory compliance (cGMP, cGDP).
• Direct QA reviews/approvals of documents supporting commissioning/qualification per project timelines.
• Represent the QA unit during audits and inspections.

Skills

People management

Quality/Operations experience

Leadership

Education

Bachelor's degree

Associate's degree

Master's degree

Doctorate

Job description

Amgen Inc. is seeking a Sr Manager QA – Quality Validation & Technical Services to lead quality oversight for the design, installation, commissioning and qualification of a new facility and equipment.

You will partner with Manufacturing, Facilities & Engineering to ensure project milestones and regulatory requirements are met. The role requires seasoned QA leadership, strong knowledge of cGMP, and the ability to influence cross-functional teams.