Quality Assurance Manager
Amgen
August 15, 2026
Remote friendly (Thousand Oaks, CA)
United States
Operations
QA Manager
Responsibilities:
- Oversee daily operations of the Quality Assurance team; implement and manage QA systems.
- Partner with manufacturing, supply chain, facilities, and engineering/automation to ensure quality, safety, and compliant operations.
- Provide quality oversight of manufacturing operations, testing, inspection, and utilities.
- Lead QA team (strategic direction, staff development, high-performance culture).
- Champion quality initiatives; drive continuous improvement projects with cross-functional teams.
- Optimize quality processes to improve efficiency and effectiveness.
- Ensure compliance with cGMP and regulatory requirements.
- Lead/support internal/external audits and inspections; interact with regulatory agencies during on-site inspections.
- Develop and manage training programs for cGMP competency.
- Manage quality issues to prevent recurrence.
- Evaluate team performance; coach for growth/professional development.
- Provide quality oversight for records (Deviations, Change Controls, CAPAs).
- Provide quality expertise to operational and cross-functional teams.
- Provide quality oversight during implementation of projects to meet plant/department goals.
- Cover different shifts as needed for 24/7 production (day/swing; some weekend coverage).
Basic Qualifications:
- Doctorate OR Master’s + 3 years quality OR Bachelor’s + 5 years quality OR Associate’s + 10 years quality OR HS/GED + 12 years quality.
- Direct people management and/or leadership experience leading teams/projects/programs or allocating resources.
Preferred Qualifications:
- BS in Science; 5+ years aseptic processing in QA/Manufacturing.
- Thorough cGMP/FDA/EMA and regulatory knowledge.
- Leadership, analytical/problem-solving, communication, attention to detail.
- Continuous improvement mindset; aseptic/cleanroom expertise.
- Risk management, operational excellence, collaboration, and audit/inspection readiness.
Benefits (Total Rewards Plan, eligibility-based):
- Comprehensive benefits (retirement/savings with company contributions, medical/dental/vision, life/disability, flexible spending).
- Discretionary annual bonus (or sales incentive for field sales), stock-based long-term incentives, time-off, and flexible work (remote/hybrid where possible).
Application instructions:
- Apply now via careers.amgen.com. No application deadline; accepts applications until filled.
Responsibilities:
- Oversee daily operations of the Quality Assurance team; implement and manage QA systems.
- Partner with manufacturing, supply chain, facilities, and engineering/automation to ensure quality, safety, and compliant operations.
- Provide quality oversight of manufacturing operations, testing, inspection, and utilities.
- Lead QA team (strategic direction, staff development, high-performance culture).
- Champion quality initiatives; drive continuous improvement projects with cross-functional teams.
- Optimize quality processes to improve efficiency and effectiveness.
- Ensure compliance with cGMP and regulatory requirements.
- Lead/support internal/external audits and inspections; interact with regulatory agencies during on-site inspections.
- Develop and manage training programs for cGMP competency.
- Manage quality issues to prevent recurrence.
- Evaluate team performance; coach for growth/professional development.
- Provide quality oversight for records (Deviations, Change Controls, CAPAs).
- Provide quality expertise to operational and cross-functional teams.
- Provide quality oversight during implementation of projects to meet plant/department goals.
- Cover different shifts as needed for 24/7 production (day/swing; some weekend coverage).
Basic Qualifications:
- Doctorate OR Master’s + 3 years quality OR Bachelor’s + 5 years quality OR Associate’s + 10 years quality OR HS/GED + 12 years quality.
- Direct people management and/or leadership experience leading teams/projects/programs or allocating resources.
Preferred Qualifications:
- BS in Science; 5+ years aseptic processing in QA/Manufacturing.
- Thorough cGMP/FDA/EMA and regulatory knowledge.
- Leadership, analytical/problem-solving, communication, attention to detail.
- Continuous improvement mindset; aseptic/cleanroom expertise.
- Risk management, operational excellence, collaboration, and audit/inspection readiness.
Benefits (Total Rewards Plan, eligibility-based):
- Comprehensive benefits (retirement/savings with company contributions, medical/dental/vision, life/disability, flexible spending).
- Discretionary annual bonus (or sales incentive for field sales), stock-based long-term incentives, time-off, and flexible work (remote/hybrid where possible).
Application instructions:
- Apply now via careers.amgen.com. No application deadline; accepts applications until filled.