External Technical Services Lead EU
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Hobson Prior currently have a new 12-month contract position for an External Technical Services Lead EU to join a patient-focused pharmaceutical organisation in Dublin. Our client is focused on offering life-changing treatments to enable people all over the world to live a healthier and brighter future.
Please note that to be considered for this role you must have the right to work in this location.
- Accountable to lead, manage and coordinate technical support activities for Biologics Drug Substance and/or Drug Product at registration and post-registration stages of the product lifecycle.
- To work closely with colleagues in Pharmaceutical Sciences, Supply Chain Operations, Quality Assurance and CMC-regulatory Affairs, while serving as a key point of technical contact between multiple contract manufacturing organisations.
- Serve as a key knowledge link between Global Manufacturing Sciences and External Biologics Operations, providing technical leadership in support of quality systems governing GMP manufacturing (e.g., deviations, investigations, CAPA and change control), regulatory submissions, and facility inspections.
- Oversee the technical review/approval for manufacturing related documents such as Change Notifications, APQR and MBR.
- To build and maintain strong relationships with key internal and external partner organizations and will be expected to develop and deliver shared objectives with key partner groups.
- Responsible for delivering on key performance indicators, including but not limited to:-
-Documentation cycle time (Technical Protocols and Reports, Regulatory Filing Support Documentations, etc).
-Right first time.
-Cost of goods and CMO productivity improvement.
- Work with the Global Manufacturing Sciences network to create or enhance technical capabilities to deliver the needed capacity, quality and quantity of products required by our patients.
- Recognise and manage process improvement activities for existing commercial manufacturing operations.
- To highlight the appropriate resources needed to quickly resolve technical issues (quality, capacity, and cost) and drive process reliability and improvements.
- Any other assigned duties.
- You are results oriented.
- An excellent manager of self and others.
- Ability to lead effectively and work concurrently across multiple projects in a goal-oriented, timeline-driven, and dynamic work environment, while ensuring quality and accuracy.
- Demonstrates innovative problem solving and analytical skills.
- Requires a degree in technical / scientific education with 5 years technical industry experience in development and/or manufacturing.
- Experience managing technical capabilities in a global capacity.
- Experience in managing medium to high complexity technical projects within a cross-functional matrixed organization.
- Broad knowledge and experience within the GMP environment, and regulatory affairs.
- Successful track record of change management projects and processes.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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