The Sr. IS Business Analyst – Quality and Compliance is a hands-on role within the IS organization to drive activities across the global IS teams to ensure validation and quality of services. Insures all systems implemented meet obligations consistent with established controls in compliance with Quidel’s Quality Management System and Testing standards in SDLC. This position requires a general knowledge of information technology on premise and cloud hosted applications & infrastructure. This position will be responsible to maintain validated state of SaaS, IaaS, PaaS used to support a medical device environment consistent with FDA standards and support internal and external regulatory audits.
- Collaborate across the enterprise to ensure quality, validation and compliance with GxP and SOX
- Conduct various IS Compliance controls validation and implementation activities. Activities may include reviewing change activities with multiple stakeholders, service/incident tickets, collecting data, generating detail and thorough documentation which demonstrates compliance with IS controls.
- Implement validation plans and protocols based on system understanding and analysis of functional and system specifications to ensure new and changes to GxP software / computer systems are maintained in a state of compliance.
- Assist the IS teams to develop system and software testing and validation documentation including reviewing and approving validation plans, reports, and specifications. Validation of cloud hosted software solutions to ensure compliance with company policies and consistent interpretation and implementation of regulatory controls and industry best practices (e.g., FDA 21 CFR Part 11, ISO13485, etc.)
- Defines Testing standards and ensures ERP Software Quality in collaboration with IS and business process owners. Identify quality and compliance concerns, ensure policies/processes are consistently applied and provide overall support on IT quality and compliance related issues.
- Serve as an interface with internal and external entities for IS reviews and audits. Coordinate requests for sample collection, compliance evidence, issues, and remediation plans. Work with IS control owners in creating, documenting, interpretation and monitoring of IT general controls.
- Ensure accuracy and completeness of Software Development Lifecycle records. Oversee the IT change management process, including governance and prompt completion of requests.
- Medium to large scale IS project management
- Coordinate with Quidel Quality Assurance team to establish consistent practices for GxP software validation across Information Systems
- Assists with strategy and processes related to all areas of IS Quality and Compliance.
- Other duties as assigned by Management
EDUCATION, SKILLS & EXPERIENCE:
- Bachelor's degree in Business or related field or equivalent experience.
- At least 10 years of working in a corporate IS or QA environment, out of which 5 to 7 years of experience must be directly related working in an IT Quality or IT Compliance role demonstrating an understanding of global IT risk and compliance standards and processes.
- Demonstrated success in project planning and execution, leading large projects with significant organizational change management is required.
- Demonstrated success in maintaining system validation through regular change management, system maintenance, and projects required.
- Experience within the healthcare, medical device, or life sciences industry is required.
- A strong understanding of Medical and FDA control frameworks, documentation and practices based on various compliance areas (FDA 21 CFR Part 11, ISO 13485, etc.) is required.
- A good understanding of IT financial control frameworks, documentation and practices based on various compliance areas (SOX, SSAE etc.) is desired.
- Must be able to work with audit teams where their independence is required. Must be able to judge boundaries, provide factual objective opinions, rationalize, etc. Must be able to work in an environment with multiple opinions/view and remain objective.
- Must have general understanding and knowledge of IT hardware concepts, cloud-based SaaS systems (Salesforce, ERP, etc.), use of application systems (ServiceNow, Databases like Oracle, SQL etc.), operating systems (Windows, Linux), Windows server management and Active Directory.
- Strong ability to utilize Microsoft Office products with focus on Excel, Word, PowerPoint, Visio, Project, and SharePoint
- Experience in Managing complex and multi-system projects.
- Experience in Business Process Testing software tools for manual and automated functional testing is highly desirable.
- Six sigma and or CISA certification is desired.
- Ability to communicate clearly and succinctly in both verbal and written communications, as well as interact and work with others in a collaborative fashion.
- Needs excellent presentation, problem-solving, and conflict resolution skills.
- Ability to work efficiently and independently with minimal supervision as well as the ability to work successfully in a cross-functional team in a complex matrix environment.
- Organized, ability to manage multiple objectives, disseminate plans, and execute quickly.