Senior QA Lead, External Supply & CMO Quality

Amgen; United States; Remote; USD 101,000 - 137,000; Full time

Job summary

Amgen is seeking a high-level Quality professional to join the team and ensure supply of high-quality product from CMOs. You will collaborate with global quality groups, manufacturing sites and contract manufacturers to support patient safety and regulatory readiness.

The role involves leading quality reviews, approvals, and inspections readiness, with extensive cross-functional interaction and strong leadership capabilities.

Qualifications

• Doctorate degree with 2 years of related experience.
• Master’s degree with 4 years of related experience.
• Bachelor’s degree with 6 years of related experience.
• Associate’s degree with 10 years of related experience.
• High school diploma / GED with 12 years of related experience.
• 10+ years biotech or pharmaceutical industry experience.
• Qualified Person status is desirable.
• Significant Quality experience in Small Molecule or Aseptic Manufacturing.
• Ability to facilitate and influence senior stakeholders and partners.
• Strong project management, problem-solving, and analytical skills.

Responsibilities

• Be an integral quality member of Amgen cross-functional contract manufacturing team.
• Lead the representation, communication and management of quality issues with internal and external partners.
• Serve as the main Quality point of contact and approver for deviations, change controls, CAPAs, and batch disposition related to Amgen product.
• Manage CMOs to contractual obligations relative to Quality Agreement, Amgen specifications, quality, safety and regulatory requirements.
• Review completed production batch records and approve master batch records and other cGMP documents from CMOs.

Skills

Biotech/pharma exp

Qualified Person (QP)

Small molecule QA

Project management

Stakeholder management

Quality assurance

GMP knowledge

Cross-functional leadership

Regulatory inspections

Risk management

Education

Doctorate + 2 yrs exp

Master’s + 4 yrs exp

Bachelor’s + 6 yrs exp

Associate + 10 yrs exp

HS diploma/GED + 12 yrs exp

Job description

Amgen is seeking a high-level Quality professional to join the team and ensure supply of high-quality product from CMOs. You will collaborate with global quality groups, manufacturing sites and contract manufacturers to support patient safety and regulatory readiness.

The role involves leading quality reviews, approvals, and inspections readiness, with extensive cross-functional interaction and strong leadership capabilities.