Therakos Healthcare Limited · 9 hours ago
IT Senior Manager, Validated Systems
Nashville Metro
Full-time
Onsite
Senior Level
5+ years expTherakos Healthcare Limited is seeking a highly skilled and experienced IT Senior Manager, Validated Systems to manage processes, systems, and tools across multiple functional areas. This role involves planning, coordinating, and executing validation activities for computer systems to ensure compliance with regulatory requirements and working closely with IT, Quality, and business stakeholders.
Pharmaceuticals
Hiring Manager
Michelle Keller
Responsibilities
Responsible for the oversight and upkeep of validated applications
Manage relationships with software vendors and service providers, ensuring service level agreements are met
Communicate with business partners to ensure awareness of status and issues, if applicable
Oversee, perform and support CSV activities for validated systems in line with GxP regulations
Author, review, and manage essential validation documentation, including User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Design Specifications, Validation Plans (VPP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Traceability Matrices, and Summary Reports
Develop and execute test scripts, capture test evidence, manage deviations, and support User Acceptance Testing (UAT) and Quality Assurance (QA) reviews
Ensure all system changes, patches, and upgrades follow established change management procedures and maintain the system's validated state. Maintain audit-readiness through rigorous documentation and configuration management
Work with Business Partners to learn about challenges and opportunities and translate that insight into high quality solutions by optimizing existing technology and identifying new capabilities
Ensure that proposed solutions align with the organization’s strategic goals and technological capabilities
Qualification
Required
Ability to work independently, exercise good judgement, and make sound decisions
In-depth knowledge of relevant regulations, guidelines, and industry standards related to CSV, data integrity, and computerized systems (e.g., GAMP 5, 21 CFR Part 11)
Strong analytical, problem-solving, and critical thinking abilities
Excellent communication and collaboration skills
Attention to detail and a commitment to data integrity and quality
At least 5 years hands-on experience with Veeva Vault RIM (Submissions & Archive)
Experience with LMS and Quality Management Systems
5+ years of experience in validation within pharmaceutical, biotech, or medical device industries
Proven experience working in GxP-regulated environments and a deep understanding of global regulations (e.g., 21 CFR Part 11, EU Annex 11)
Experience with audit preparation and participation
Experience with integration testing, data migration and data quality validation
Bachelor's degree in Computer Science, Information Technology, or equivalent practical experience
Benefits
Medical, Dental, Vision Insurance
Life/AD&D
Short- and Long-Term Disability
401(K) with large company match
Health Saving Account (HSA) and Flexible Spending Account (FSA) with company match
Wellness Program
Employee Assistance Program (EAP)
Generous Paid Time Off (PTO)
Company
Therakos Healthcare Limited
Please visit our regional websites for product information.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase