Group Analyst: Regulatory and Quality Applications
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Key skills for this role
About the Role
Aspen Holdings seeks a Group Analyst for Regulatory and Quality Applications to administer, configure, and support systems like eQMS, RIMS, Document Control, and Audit & Compliance.
Key Skills for This Role
Responsibilities
- Administer, configure, and support systems used for regulatory, quality, and compliance operations
- Support enterprise platforms such as eQMS, RIMS, Document Control, Audit & Compliance systems, and other regulatory/quality tools
- Ensure systems are maintained in a validated state, operated securely, and aligned with global regulatory standards
- Support Regulatory and Quality teams with reliable system access, troubleshooting, training, documentation, and coordination of system changes
- Work with IT, vendors, and auditors to maintain data integrity, compliance, and continuous improvement
Requirements
- Operational role responsible for administration, configuration, and support of regulatory, quality, and compliance systems
- Support enterprise platforms such as eQMS, RIMS, Document Control, Audit & Compliance systems, and other regulatory/quality tools
- Ensure systems are maintained in a validated state, operated securely, and aligned with global regulatory standards including GxP, 21 CFR Part 11, ISO 9001, and ISO 13485
- Support Regulatory and Quality teams with reliable system access, troubleshooting, training, documentation, and coordination of system changes
- Work with IT, vendors, and auditors to maintain data integrity, compliance, and continuous improvement
Full Job Posting
Overview
- Operational role within the Group Digital Technology team responsible for the administration, configuration, and support of systems used for regulatory, quality, and compliance operations across the organization.
- The Group Analyst serves as an application specialist supporting enterprise platforms such as eQMS, RIMS, Document Control, Audit & Compliance systems, and other regulatory/quality tools.
- The role ensures systems are maintained in a validated state, operated securely, and aligned with global regulatory standards, including GxP, 21 CFR Part 11, ISO 9001, and ISO 13485.
- The incumbent supports the Regulatory and Quality teams with reliable system access, troubleshooting, training, documentation, and coordination of system changes, while working with IT, vendors, and auditors to maintain data integrity, compliance, and continuous improvement.
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