Global Quality Compliance Lead: Audits, Inspections & Strategy

Regulatory Jobs; Puerto Rico; Hybrid; USD 138,000 - 187,000; Full time

Benefits offered by this job

Retirement and savings plan

Medical, dental and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Job summary

Amgen seeks a Senior Manager for Global Quality Compliance to lead audits of the Corporate Quality Management System, facilities, and suppliers. You will oversee training, development of annual audit plans, and issue resolutions to ensure regulatory readiness.

Travel is roughly 50% domestically and internationally; the role requires strong regulatory expertise and leadership to guide cross-functional teams through complex quality challenges.

Qualifications

• Experience in global quality audits and program oversight.
• Deep knowledge of GMP, GLP, and regulatory expectations.
• Proven ability to lead cross-functional audit teams and projects.
• Strong leadership and people-management skills.

Responsibilities

• Plan and execute Global Quality Compliance audits across sites, affiliates, and suppliers.
• Lead and mentor audit teams; escalate risks to senior management.
• Support regulatory inspections and responses; contribute to action plans.
• Contribute to Continual Improvement initiatives and QMS optimization.

Skills

Auditing

Leadership

Regulatory knowledge

Education

Doctorate + auditing experience

Master's degree in related field

Bachelor's degree in related field

CQA certification desired

Tools

CQA certification

Job description

Amgen seeks a Senior Manager for Global Quality Compliance to lead audits of the Corporate Quality Management System, facilities, and suppliers. You will oversee training, development of annual audit plans, and issue resolutions to ensure regulatory readiness.

Travel is roughly 50% domestically and internationally; the role requires strong regulatory expertise and leadership to guide cross-functional teams through complex quality challenges.