Amgen
Biotechnology
ManagerIncomingQualityAssurance(IQA)
Neural analysis suggests this role is
optimal for Manager candidates.
“Manager Incoming Quality Assurance (IQA) at Amgen. Skills: Incoming Quality Assurance, People management, Process improvement. Lead Incoming Quality Assurance team. Ensure quality and compliance”
Industry & Context.
Analytical mindset; Risk-based approach; Root cause analysis
What They're Looking For.
Must Have
Master's degree in Pharmaceutical Sciences or Life Sciences, 3+ years GMP-regulated environment, Experience in people management, Proven experience in investigations, Proven experience in CAPAs, Proven experience in process improvement
Nice to Have
Experience in pharmaceutical industry, Experience in supplier management, Familiarity with deviations, Familiarity with CAPAs, Familiarity with change control processes, Knowledge of risk management tools
What You'll Do.
Lead Incoming Quality Assurance team
Ensure quality and compliance
Oversee Incoming Quality processes
Execute processes efficiently
Execute processes consistently
Execute processes in compliance
Act as decision-maker within QA
Review and approve deviations
Review and approve CAPAs
Review and approve change controls
Act as Subject Matter Expert
Drive continuous improvement initiatives
Analyze team performance
Identify most valuable improvements
Ensure inspection readiness
Drive process improvements
Participate in key projects
Participate in key programs
Collaborate with Supply Chain
Collaborate with Manufacturing
Collaborate with Warehouse teams
How You'll Work.
Team & Collaboration
Cross-functional stakeholders; Supply Chain; Manufacturing; Warehouse teams
Process & Methodology
Process improvement, Key projects, Key programs
Full Job Description
## **Career Category** Quality ## ## **Job Description** If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us as: **QA Manager – Incoming Quality Assurance (IQA)** At Amgen Breda medicines are labelled, assembled, stored and eventually shipped to various countries worldwide. Every day more than 1000 people with 42 different nationalities are working on supply chain processes, manufacturing, marketing and sales of our medicines and clinical research into new medicines. **Live** **What you will do** In this vital role, you will lead the Incoming Quality Assurance (IQA) team in Breda, ensuring high standards of quality and compliance across incoming materials and processes. You will play a key role in shaping a strong quality culture while developing and empowering your team to perform at their best. You will oversee the end-to-end Incoming Quality processes, ensuring they are executed efficiently, consistently, and in full compliance with GMP and regulatory requirements. At the same time, you will act as a key decision-maker within QA, bringing a risk-based mindset to quality-related topics. Your main responsibilities will include: * Leading, coaching, and developing the IQA team, including hiring and performance management * Ensuring effective sampling, inspection, and disposition of incoming materials * Reviewing and approving deviations, CAPAs, and change controls in line with quality standards * Acting as Subject Matter Expert (SME) for Incoming Quality and driving continuous improvement initiatives * Use of digital tools and technologies to analyse team performance and identifying most valuable im
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