Director, Quality Compliance & Regulatory Readiness

Amgen SA; Holly Springs (NC); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision coverage

Bonus program

Stock-based incentives

Time-off plans

Flexible work model

Job summary

Amgen seeks a Director of Quality Compliance to lead GMP compliance initiatives and regulatory readiness across new sites and expansions of manufacturing facilities. You will partner with QA and cross-functional teams to ensure sustained quality systems and regulatory alignment.

Ideal candidates bring extensive GMP experience, a strong track record in regulatory submissions, and the ability to guide complex investigations and accuse continuous improvement while supporting digital strategies.

Qualifications

• Bachelor’s degree required with 9 years of Quality Compliance experience, or Master’s with 7 years, or Doctorate with 4 years.
• Strong GMP compliance, inspection readiness, and regulatory knowledge required.
• Experience supporting drug substance/bulk manufacturing operations preferred.

Responsibilities

• Provide compliance support for deviations investigations and inspection topics.
• Lead/regulatory communications and responses to regulatory filings and inquiries.
• Support readiness for regulatory inspections and provide cross-functional guidance.
• Draft/review regulatory communications and inspection responses.
• Lead strategy during regulatory inspections and coordinate cross-functional teams.
• Develop inspection playbooks and ensure staff readiness.
• Advise on new technologies and changes to quality processes.

Skills

Quality Compliance

Regulatory readiness

GMP knowledge

Audit leadership

Education

Bachelor's degree

Master's degree

Doctorate degree

Job description

Amgen seeks a Director of Quality Compliance to lead GMP compliance initiatives and regulatory readiness across new sites and expansions of manufacturing facilities. You will partner with QA and cross-functional teams to ensure sustained quality systems and regulatory alignment.

Ideal candidates bring extensive GMP experience, a strong track record in regulatory submissions, and the ability to guide complex investigations and accuse continuous improvement while supporting digital strategies.