Director, Application Administration
Asklepios BioPharmaceutical, Inc. (AskBio) is a clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy pioneers, Jude Samulski, PhD, and Xiao Xiao, PhD. We are driven to change lives with every clinical advancement and turn hope into cures with new possibilities for genetic medicine. We currently have clinical trials ongoing for late-onset Pompe disease and congestive heart failure.
AskBio is headquartered in Research Triangle Park, North Carolina, a thriving biotechnology hub, and has additional research and development facilities in Edinburgh, Scotland, and gene therapy manufacturing in San Sebastian, Spain.
We are excited for our next Director, Application Administration to join the AskBio team!
About the role
Responsible for managing administration of AskBio applications including Rees Monitoring Systems, Asset Essentials CMMS, Benchling ELN and the ERP, as well as additional applications that may be deployed as the organization continues to grow. Duties include managing Level 2 support and configuration of all applications including application configuration to meet business needs, vendor management, account management, upgrade management and 21 CFR Part 11 Compliance where appropriate. Responsible for building the Application Administration team to support anticipated company growth.
Responsibilities and accountabilities
- Handles Level 2 responsibilities for production systems. Level 2 support is required when Level 1 support, on-call support, cannot address the identified issue
- Manages the configuration of applications to meet business needs
- Supports IQ, OQ, PQ efforts related to validated systems in collaboration with validation
Engineering & QA
- Plans and manages vendor upgrades, including change control where appropriate, to maintain currency of applications
- Develops and maintains knowledge-base information related to respective application configurations
- Provides guidance and mentoring in the area(s) of technical expertise
- Evaluates new products and services based on business requests for application support
- Responsible for configuring new users in applications
- Responsible access management, and periodic review of access, such that end-users have the minimal access to applications needed to perform their responsibilities
- Participates in the development and implementation of procedures to minimize service outages and ensures appropriate communication to the end users; includes authoring SOPs
- Works to constantly improve customer service
- Provide onboard training for new employees for supported applications
- Provide group training for employees on new applications and features
- Plan, manage and implement configuration requests for all 3rd party clinical systems
- Coordinate with teams and vendors to resolve all complex application and system issues
- Administer and resolve applications issues, provide updates and perform root cause analysis
- Develop, sustain and evaluate delegated business processes and related applications
- An undergraduate degree or equivalent in Computer Science, Information Systems, Systems Engineering, Management Information Systems or related. At least 10-year experience in Application Administration in a 21 CFR Part 11 environment
- Demonstrated ability to efficiently work with different personalities and styles and prioritize activities based on ambiguous or quickly changing information and environments is critical
- Ability to multitask among projects and teams and work independently in a fast-paced, highly interactive environment
- Excellent interpersonal skills with the ability to interact effectively with people internally and externally are required
- Must be self-motivated, organized, capable of working independently, as well as in a collaborative/group environment
- Should possess strong oral and written communication skills
- Good judgment and innovation to achieve a solution within standard practices and procedures
- Experience with the administration of clinical systems
- Be able to recruit and train additional team members as needed
- Position requires the ability to act independently and take initiative with minimal supervision
- This role has no spending authority except through the request process
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