Remote Senior QA Manager: Supplier Quality & Compliance

Amgen SA; Puerto Rico; Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based long-term incentives

Flexible work models

Retirement and Savings Plan

Comprehensive benefits package

Job summary

Amgen is seeking a Quality Assurance Senior Manager to oversee the quality oversight of primary component suppliers and collaborate with cross-functional teams across operations, process development, supply chain, and manufacturing. The role emphasizes regulatory compliance, audits, and risk management to ensure high-quality materials for patients.

You will lead supplier quality programs, prepare sites for regulatory inspections, and drive continuous improvement initiatives while partnering with

Qualifications

• Doctorate, Master’s, Bachelor’s, Associate’s, or High School with extensive quality experience.
• 10+ years biotech/pharma experience preferred.
• Experience overseeing supplier quality and leading audits.
• Strong knowledge of GMP GDP ISO and regulatory expectations.

Responsibilities

• Quality lead for supplier relationships from onboarding to disengagement.
• Ensure compliance with GDP, GMP, ISO and Amgen standards.
• Negotiate and own quality agreements.
• Prepare sites for inspections and develop inspection playbooks.
• Represent Amgen at supplier inspections and audits.
• Review and approve supplier investigations and deviations.
• Drive supplier audit preparation and closure.

Skills

Quality management

Supplier relationships

Audit leadership

Regulatory knowledge

Risk assessment

Cross-functional leadership

Project management

Data analytics

Stakeholder influence

GMP GDP ISO knowledge

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

Trackwise

Veeva

Job description

Amgen is seeking a Quality Assurance Senior Manager to oversee the quality oversight of primary component suppliers and collaborate with cross-functional teams across operations, process development, supply chain, and manufacturing. The role emphasizes regulatory compliance, audits, and risk management to ensure high-quality materials for patients.

You will lead supplier quality programs, prepare sites for regulatory inspections, and drive continuous improvement initiatives while partnering with