Manager, Development Quality Documentation and Training

Job title:

Manager, Development Quality Documentation and Training

Company

Alexion Pharmaceuticals

Job description

This is what you will do:The Manager manages technical and logistical services in compliance with document and system standards within the document management system and supports Development, Regulatory and Safety and the broader R&D organization with LMS curricula maintenance. Â Contributes to the implementation and conduct maintenance activities of systems, platforms, and processes in the remit of the Development Quality team. Acts as a point of contact and support related to these systems.You will be responsible for:

• ECMS (Enterprise Content Management System) Documentation Enablement and System Support
• Supports governance and compliance of documents and training
• Delivers guidance and document management service related to the systems
• Conducts maintenance activities related to ECMS and agreed related applications
• Interacts and collaborates with the ECMS Functional Lead, as well as other key Stakeholders, related to ECMS Documentation to achieve a good understanding and working practices related to Document Management and the use of ECMS system
• Interacts and collaborates with the Business Process Owner (BPO) for Manage Procedural Documents to achieve a good working practice related to the use of ECMS system and procedural documents
• Provides metrics and creates reports in the ECMS
• Supports inspections
• Analyses the queries from the user community to identify improvement opportunities in reference materials & system functionality supporting all types of documents in ECMS and escalates findings.Â
• Support functions in maintaining LMS curricula for training assignments.
• Liaison with AZ R&D Learning Services and GLS for Alexion job roles
• Analyses the queries from the user community to identify improvement opportunities in reference materials & system functionality supporting the learning management system.Â

You will need to have:

• Bachelor’s Degree in life sciences or similar scientific subject

• 5+ years of experience in pharmaceutical quality
• GxP Document and Learning Management systems knowledge
• Excellent analytical, written and oral communications skills
• Proven expertise in system administration and information management
• Strong collaborative, influencing and interpersonal skills – curious to understand business environment
• Ability to maintain and create professional networks with stakeholders

• High attention to detail and accuracy
• High ethical standards, trustworthy, operating with absolute discretion
• Excellent communication skills; fluent oral and written English
• Skilled at managing & using technology
• Ability to maintain and create professional networks with stakeholders

We would prefer for you to have:

• Good analytical, problem-solving and negotiation skills
• Experience in working in a global role
• Cultural Awareness and Positive attitude in managing change
• Project Management experience

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Expected salary

Location

Dublin

Job date

Wed, 05 Feb 2025 23:06:44 GMT

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