Global Senior Product Quality Leader

Amgen SA; Northern (KY); Hybrid; USD 180,000 - 250,000; Full time

Job summary

Amgen seeks a Product Quality Director to lead the Product Quality organization, driving technical expertise, strategic direction, and project leadership across PQ, Regulatory, and Manufacturing functions. The role involves overseeing stability programs, specifications, comparability, regulatory filings, and inspections, with accountability for the PQT and its staff.

The successful candidate will possess a doctorate or master’s with extensive quality and regulatory experience, strong leadership,

Qualifications

• Doctorate or Master’s with extensive experience in Quality/Manufacturing.
• Strong knowledge of regulatory filings and inspections (cGMP).
• Experience leading Product Quality teams in biotech/pharma.

Responsibilities

• Provide cross‑functional quality leadership for late phase and commercial programs.
• Mentor PQ team members and align with PQT/APR and regulatory filing sections.
• Oversee product quality programs including comparability, stability, and regulatory interactions.
• Communicate complex information to Amgen leadership and regulatory agencies.
• Support regulatory audits and responses; ensure adherence to cGMP and global expectations.
• Lead a Product Quality Team and drive continuous process improvements.

Skills

Product Quality Leadership

Cross-functional leadership

Regulatory knowledge

cGMP knowledge

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Job description

Amgen seeks a Product Quality Director to lead the Product Quality organization, driving technical expertise, strategic direction, and project leadership across PQ, Regulatory, and Manufacturing functions. The role involves overseeing stability programs, specifications, comparability, regulatory filings, and inspections, with accountability for the PQT and its staff.

The successful candidate will possess a doctorate or master’s with extensive quality and regulatory experience, strong leadership,