Clinical Supply Chain Manager - Change Control and Deviations

Clinical Supply Chain Manager Change Control & Study Setup Support (GCF 5)

Role Description

In this vital role, you will serve as the Manager Clinical Supply Chain, managing Compliance Records related to Clinical Product Life Cycle Changes (Change Control, Deviations and CAPA’s) as record owner, and in addition leading a team of two Senior Associates supporting Study Design Setup deliverables across the global team in ABR and ATO.  

Reporting to the Senior Manager Development Supply Chain, you will provide people leadership and operational oversight for the Study Setup Support Office, and as the owner of Compliance Records you will partner closely with key stakeholders across Operations, Clinical Quality, R&D, and the change control team in ABR.

In close collaboration with the Global Setup Lead team,  you will ensure reliable, compliant, and right-first-time process execution, while strengthening operational rigor, process discipline, and performance visibility.

The role is accountable for managing efficient and effective execution of study setup (GMP) deliverables, such as Depot Plans, Product Specification Files and Master data requests.
You will oversee workload prioritization, performance management, risk mitigation, and continuous improvement initiatives of the team, ensuring alignment with the global clinical supply chain priorities, regulatory requirements, and financial objectives.

Roles & Responsibilities

People Leadership & Team Development

• Lead and develop team of 2 Senior Associates for Support Office Activities
• Define goals, manage performance, and support career development.
• Ensure appropriate staffing, cross-training, and succession planning.
• Foster a culture of accountability, compliance, and customer focus
• Drive adoption of new technologies and AI to increase team productivity and enhance performance

Compliance Record Management

• Owning and project managing Change Control Records related to Clinical Product Life Cycle changes, or clinical protocol amendments
• Owning (major) deviation records
• Owning Corrective Action/ Preventative Action  (CAPA) records

Clinical Supply Chain Execution Oversight

• Ensure efficient and compliant execution of assigned clinical supply chain processes with patient-centric mindset
• Closely coordinate issue triage and workload prioritization with global peers
• Monitor KPIs and overall team performance and drive corrective actions when needed.
• Provide guidance on complex operational matters.
• Ensure adherence to GMP, GDP, and regulatory requirements.

Performance & Process Management

• Ensure procedures are current, compliant and inspection-ready
• Drive root cause analysis and continuous improvement.
• Represent the team during audits and inspections.

Cross-Functional & Global Collaboration

• Partner with Global Clinical Supply Chain, Clinical Study Teams, Quality and Regulatory Affairs
• Translate global priorities into actionable local plans.

Compliance & Governance

• Ensure execution in compliance with all applicable regulatory guidelines and Amgen procedures.

Qualifications

• Bachelor degree or equivalent in logistics, business administration or life science.
• 5 year’s relevant working experience, preferably in the biotechnology or pharmaceutical industry,
• 5 year’s relevant working experience in an international and regulated environment
• Advanced understanding of fundamentals of logistics principles
• 3 year’s relevant working experience in project leadership and project management techniques
• Advanced experience in MS Office applications
• Fluency in English, both in oral and written communication
• High quality standards with regards to work
• Ability to set priorities and timely escalation
• Strong communicating and facilitating issue resolution skills

Preferred requirements

• Knowledge of clinical supply chain management
• General understanding of regulatory guidelines impacting clinical supplies (i.e. GxP, International Conference on Harmonization (ICH) guidelines, Clinical Trial Directive)
• Experience in managing change control records
• Experience in managing deviation and CAPA records
• Knowledge of SAP or similar ERP systems