IT Senior Manager, Validated Systems

Overview

We are seeking a highly skilled and experienced IT Senior Manager, Validated Systems to play a critical role in the on-going management of processes, systems and tools for multiple functional areas. This role is responsible for planning, coordinating, and executing validation activities for computer systems to ensure compliance with regulatory requirements. This role involves working closely with IT, Quality, and business stakeholders to validate new and existing systems, document validation evidence, and support audits and inspections.

The ideal candidate will have a strong background in computer system validation, excellent leadership skills, and a deep understanding of business processes and technology solutions. Additional duties as assigned.

Skills:

• 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

Experience:

• 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

• Application Ownership:
• 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.
• Computer System Validation (CSV):
  Oversee, perform and support CSV activities for validated systems in line with GxP regulations.
• Documentation Management:
  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.
• Testing & QA:
  Develop and execute test scripts, capture test evidence, manage deviations, and support User Acceptance Testing (UAT) and Quality Assurance (QA) reviews.
• Change Control & Compliance:
  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.
• Business
  
  Collaboration:
  
  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.

Office based role in Radnor, PA or Franklin, TN.

• 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)

Disclaimer:
The included statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.