Slipstream IT ยท 2 months ago
Senior Business Analyst, Pharma Information Systems - GXP - Remote, US
United States
Full-time
Remote
Senior Level
$85/hr - $95/hr
6+ years expSlipstream IT is a company that provides managed IT solutions for emerging pharma and biotech organizations. The Sr Business Analyst is responsible for analyzing and optimizing computerized systems to ensure compliance with GMP/GxP regulations, including gathering requirements, creating validation documentation, and supporting system implementations.
ConsultingInformation ServicesInformation Technology
Responsibilities
Requirements and analysis: Elicit, document, and manage business and system requirements, translating them into functional specifications while working with stakeholders
Validation and compliance: Lead and support GxP validation activities, including writing and executing test protocols (e.g., IQ/OQ/PQ) and maintaining traceability between requirements and validation evidence
Documentation: Create and maintain controlled documentation, such as Standard Operating Procedures (SOPs), User Requirement Specifications (URS), validation plans, and test reports
Data and process improvement: Analyze data to identify and implement process improvements using digital tools and provide data-driven insights to support decision-making
System and project support: Participate in project teams, provide support for GxP-relevant systems (like LIMS, CTMS, or EDMS), and help manage the lifecycle of these systems
Ensure all system and validation documentation is current and complete to maintain readiness for internal and external audits
Identify opportunities to improve project, program and operational efficiencies
Must have strong analytical and problem-solving skills and be able to work under pressure. They should also be able to multitask and guide and motivate others
Qualification
Required
Minimum 6-10 Years pharmaceutical manufacturing, drug safety and clinical IT business analysis
Proven successful work experience in a regulated pharmaceutical, biotech, or life sciences environment with deep GMP/QA/validation knowledge is required
Familiarity with pharmaceutical manufacturing, drug safety, clinical trials, and healthcare claims processing and systems (e.g., LIMS, MES, ELN, SCADA, CMMS) is required
Strong knowledge of GMP, GxP, GLP, and FDA 21 CFR Part 11 compliance, ensuring regulatory adherence in drug development and supply chain operations
Proficiency in data analysis tools (e.g., SQL, PowerBI, Excel, Tableau, Spotfire)
Expertise in LIMS (LabWare), CTMS (Veeva Vault, Medidata), and EHR integration (HL7, FHIR, EDI 837/835 transactions) to enhance interoperability
Experienced in gathering, analyzing, and documenting business and functional requirements (BRDs, FRDs) while mapping AS-IS and TO-BE workflows to optimize business processes
Hands-on experience in Pharmacovigilance & Adverse Event Reporting (MedWatch, EudraVigilance, ICSR) for improved drug safety monitoring
Understanding of system development life cycle (SDLC) and computer software validation (CSV) methodologies
Knowledgeable in creating user stories in JIRA, defining functional and technical requirements for automating drug safety case processing and lab sample testing workflows
Excellent Microsoft Office computer skills (Word, Excel, PPT, Visio, Onenote)
Excellent analytical and problem-solving skills, strong written and verbal communication, attention to detail, and the ability to manage relationships and influence stakeholders across departments
Ability to present concepts and lead discussions on design issues with authority and poise both internally and to clients (this is a client-facing role)
Ability to articulate complex concepts in a simple and coherent manner, both verbally and in writing
Ability to collaborate and relate to team members from a large variety of backgrounds on a daily basis. Must have experience working with local and virtual teams (including offshore)
Ability to operate with limited oversight and needs to command the respect of a broad range of business and technology stakeholders
Ability to manage multiple fast-paced projects simultaneously
A Bachelor's degree in a relevant field such as Pharmacy, Life Sciences, Information Technology, or Business is required
Preferred
Certifications: Professional certifications in Business Analysis (e.g., CBAP) or project management (PMP, Scrum Master) are strongly preferred
Company
Slipstream IT
Slipstream IT provides IT outsourcing, managed services, and consulting services for emerging biotech and pharma companies.
201-500 employees
H1B Sponsorship
Slipstream IT has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (7)
2023 (1)
2022 (1)
2021 (4)
Funding
Current Stage
Growth StageTotal Funding
unknown2025-08-05Private Equity
Leadership Team
Brandon McKay
Chief Executive Officer
Recent News
globallegalchronicle.com
2025-08-08
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