Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion AstraZeneca Rare Disease, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
This is what you will do:
This position will be accountable for project and service management of IT Laboratory and QA systems across the Alexion Quality and Manufacturing Science and Analytical Technology (MSAT) functions.
Alexion’s strategic goals and growth trajectory demand that we strive for operational streamlining and efficiency driven by lean digital solutions and processes.
As a key point of contact for the Quality Control and MSAT Labs, you will act as IT System Owner for a number of critical lab systems. This will involve oversight and accountability for BAU service management and IT support; along with IT projects and upgrades for the labs; working with our external partners and vendors.
You will be responsible for:
Key responsibilities of the Senior Manager, IT Digital Lab Lead are:
- Handling end-to-end lifecycle of laboratory systems from procurement and sourcing through implementation and validation, BAU service management and decommissioning.
- Serving as IT System Owner for critical lab systems.
- Developing and implementing technology strategy and roadmap for lab systems.
- Identifying process improvement opportunities and advocating for standard methodologies and automation.
- Providing experienced advice on technology best practices and compliance.
- Leading IT demand and enhancement requests.
- Engaging with business for quality record management.
- Overseeing IT service management of lab systems including request, incident and IT change management, security and system administration (e.g. access, licence, availability, vulnerability and patch management), continuity management (e.g. backup and disaster recovery) and periodic review.
- Leading major incidents and coordinating with support teams.
- Handling financial management of projects and operational spend.
- Maintaining relationships with external vendors and providing audit support for lab systems.
You will need to have:
- Bachelor's degree or equivalent experience in Computer Science, Information Technology, Science, Engineering or a related field.
- Experience (5+ years) working in GxP Quality and Laboratory Systems Domain
- Direct experience working with the following systems:
- Laboratory Information Management Systems (e.g. LabWare LIMS)
- Lab Execution Systems (e.g. Biovia ONE Lab LES)
- Chromatography Data Systems (e.g. Empower 3 CDS)
- Document Management Systems (e.g. Veeva Vault QualityDocs)
- Quality Management Systems (e.g. Veeva Vault QMS)
- Validation Lifecycle Management Systems (e.g. ValGenesis and Kneat Gx)
- Scientific Data Management Systems (e.g. Waters NuGenesis SDMS)
- Computer Systems Validation and GAMP 5 experience
- Analytical Instrument Validation and USP 1058 experience
- Experience of Administerining On-Premises Infrastructure and Cloud Hosting
- Experience with Administration of Segregated Lab Networks
- Experience with IT Endpoint Asset Management
- IT Service Management (e.g. ITIL 4 certification)
- IT Project Management (e.g. CAPM, PMP certification)
- Experience (3-5 years) of Partner Relationship and Communication Management
- Experience (3-5 years) of Product/System Ownership and Governance
We would prefer for you to have:
- Master’s Degree or equivalent experience in Computer Science, Information Technology, Science, Engineering or a related field.
- IT Product Owner Certification (e.g. Certified Scrum Product Owner [CSPO] )
- IT Solution Architecture Certification (e.g. AWS Solutions Architect)
- Demonstrable leadership in leading multiple system and data initiatives
- Proven track record of successful systems project delivery
- Commercially focused with high enthusiasm and energy
- Good communication, analytical, and decision-making skills
- Self-starter with the ability to work independently
- Flexibility for international travel and adaptability to a multicultural environment
Date Posted
02-Oct-2024
Closing Date
02-Oct-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.