The primary role of the QC Project Manager (Stability Project) is to support all aspects of the transition of Stability Programme Management from Amgen Colorado to Amgen Dun Laoghaire.
This role will help lead cross functional teams from Amgen sites to ensure stability programme activities are set up at ADL to support DP requirements.
Amgen are seeking a highly motivated individual to function as a Project Manager to ensure that the project is delivered on time to a high standard by applying the knowledge, skills, tools and techniques of project management to ensure optimal execution of programs/projects and continuous improvement initiatives.
The role will be responsible and accountable for:
Project Manage the overall Stability Transfer for QC and employs project management techniques
Thorough understanding of company business priorities, strategy and direction
Co-ordination of shipments, samples, materials and critical reagents
Co-ordination of reports and protocols.
Co-ordination of storage requirements and LIMS updates.
Provide ongoing support throughout study lifecycle.
The role will require strong Project management skills, some travel when required and flexible hours.
The QC Project Manager is an active role within the broader QC function and will report to QC Senior Manager/Director.
Responsibility and oversight for the development and provision of support to the Stability transition via the appropriate Amgen quality systems and compliance structures.
QC Project Manager may be cross trained and/or assigned additional project specific duties, including continuous improvement/operational excellence initiatives.
General QC Project Manager:
Ownership, accountability and provision of support to Stability Programme transition and Subject Matter
Expertise for key process such as sample handling, storage facilities, analytical methods, critical reagents, associated documentation.
Perform all activities in compliance with Amgen safety standards and SOPs
Involved with change control and NC/CAPA records and provide active input for QC
Problem Solving
Works on, and anticipates, abstract and complex problems requiring evaluation of intangible variables.
Develops innovative and creative output based on interpretation and analysis;
- Opportunity/risk analyses, - Cost/benefit analyses, - Pricing models
Integrates trends, data and information into plans, deliverables and recommendations
Develops methods and techniques based on project objectives
Autonomy
Work is guided by business plans for the discipline.
Actively participates in setting function/department objectives to meet plans.
Manages key projects or business processes.
Guides completion of major projects.
Contribution
Contributes to the function/department through responsibility for delivery of end results and contribution to planning for the department/unit
Uses strong relationships to identify requirements and potential opportunities
Provides thought leadership, guidance and advice in own field Works with resource managers from across the organisation to effectively obtain and allocate resources to complete programs and projects on time
Systems / Equipment:
MS Office, MS Project, MS VisJob Description
The primary role of the QC Project Manager (Stability Project) is to support all aspects of the transition of Stability Programme Management from Amgen Colorado to Amgen Dun Laoghaire.
This role will help lead cross functional teams from Amgen sites to ensure stability programme activities are set up at ADL to support DP requirements.
Amgen are seeking a highly motivated individual to function as a Project Manager to ensure that the project is delivered on time to a high standard by applying the knowledge, skills, tools and techniques of project management to ensure optimal execution of programs/projects and continuous improvement initiatives.
The role will be responsible and accountable for:
Project Manage the overall Stability Transfer for QC and employs project management techniques
Thorough understanding of company business priorities, strategy and direction
Co-ordination of shipments, samples, materials and critical reagents
Co-ordination of reports and protocols.
Co-ordination of storage requirements and LIMS updates.
Provide ongoing support throughout study lifecycle.
The role will require strong Project management skills, some travel when required and flexible hours.
The QC Project Manager is an active role within the broader QC function and will report to QC Senior Manager/Director.
Responsibility and oversight for the development and provision of support to the Stability transition via the appropriate Amgen quality systems and compliance structures.
QC Project Manager may be cross trained and/or assigned additional project specific duties, including continuous improvement/operational excellence initiatives.
General QC Project Manager:
Ownership, accountability and provision of support to Stability Programme transition and Subject Matter
Expertise for key process such as sample handling, storage facilities, analytical methods, critical reagents, associated documentation.
Perform all activities in compliance with Amgen safety standards and SOPs
Involved with change control and NC/CAPA records and provide active input for QC
Problem Solving
Works on, and anticipates, abstract and complex problems requiring evaluation of intangible variables.
Develops innovative and creative output based on interpretation and analysis;
- Opportunity/risk analyses, - Cost/benefit analyses, - Pricing models
Integrates trends, data and information into plans, deliverables and recommendations
Develops methods and techniques based on project objectives
Autonomy
Work is guided by business plans for the discipline.
Actively participates in setting function/department objectives to meet plans.
Manages key projects or business processes.
Guides completion of major projects.
Contribution
Contributes to the function/department through responsibility for delivery of end results and contribution to planning for the department/unit
Uses strong relationships to identify requirements and potential opportunities
Provides thought leadership, guidance and advice in own field Works with resource managers from across the organisation to effectively obtain and allocate resources to complete programs and projects on time
Systems / Equipment:
MS Office, MS Project, MS Vis
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
