Amgen · 6 hours ago
Senior Manager Quality Control Support
Amgen is a leading biotechnology company dedicated to serving patients with serious illnesses. The Senior Manager of Quality Control Support will oversee key support functions within the QC organization, ensuring compliance with cGMP standards and leading a high-performing team to optimize laboratory operations.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Lead and develop a high-performing QC support team with expertise in lab operations, documentation, and compliance systems
Drive alignment between site QC operations and global Amgen quality policies and procedures
Ensure QC operations maintain inspection readiness at all times
Own and oversee laboratory deviation investigations, CAPA management, change control, and document lifecycle
Oversee implementation and maintenance of LIMS, Empower, and other QC systems
Manage QC scheduling, sample logistics, and coordination with internal/external stakeholders
Lead and support digital and lean initiatives to improve lab efficiency, throughput, and compliance
Recruit, mentor, and develop team members to build a robust talent pipeline
Partner with Quality Assurance, Analytical Sciences, Manufacturing, and Regulatory to ensure seamless quality operations
Qualification
Required
High school diploma / GED and 12 years of Quality Analytical testing experience OR
Associate's degree and 10 years of Quality Analytical testing experience OR
Bachelor's degree and 8 years of Quality Analytical testing experience OR
Master's degree and 6 years of Quality Analytical testing experience OR
Doctorate degree and 2 years of Quality Analytical testing experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred
Master's degree or higher in a scientific or quality-related discipline
Experience in new facility start-up or tech transfer projects
Expertise in global regulatory requirements (FDA, EMA, etc.)
Strong background in laboratory compliance, LIMS, LMES, CIMS, Veeva and Trackwise systems
Lean Six Sigma or continuous improvement certification
Exceptional communication, leadership, and problem-solving skills
2+ years of management experience at a senior level
Strong Leadership, Collaboration and Communication skills
Benefits
Competitive and comprehensive Total Rewards Plans
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Recent News
2026-01-16
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