Senior Business Analyst, Pharma Information Systems - GXP - Remote, US

Introduction

At Slipstream IT we work to streamline IT Support and provide managed solutions with a strategic consulting and global leadership management approach. Our solutions are designed exclusively for emerging pharma and biotech organizations.

Slipstream’s industry-leading solutions free clients from the demands of internal IT and allow them to rapidly advance their mission. Led by a leadership team that has been together for over 10 years, you will join a proven team, culture, and strategy to drive innovation within the IT outsourcing industry while developing your skillset with the opportunities for internal growth.

Job Summary

The Sr Business Analyst, Pharma Information Systems - GXP is responsible for analyzing and optimizing computerized systems to ensure compliance with Good Practice (GMP/GxP) regulations. Key duties include gathering and documenting requirements, creating validation documentation like URS, FRS, and IQ/OQ/PQ protocols, and ensuring adherence to quality policies and audit readiness. They also perform data analysis, support system implementations, and manage documentation to support business and regulatory objectives.

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.

Qualifications

• 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.

Technical Knowledge

• 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).

Soft Skills

• 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.

Education

• A Bachelor's degree in a relevant field such as Pharmacy, Life Sciences, Information Technology, or Business is required.
• Certifications: Professional certifications in Business Analysis (e.g., CBAP) or project management (PMP, Scrum Master) are strongly preferred.

Work Schedule

• Typical schedule will be Monday to Friday, 8:00 AM to 5:00 PM EST.
• Must be flexible to accommodate departmental needs and client/staff time zones.
• At times, overtime maybe needed to accomplish deliverables which could include evenings or weekend hours.

Work Location

• Place of employment is expected to be 90% remote.
• For all remote meetings, there is an expectation of being on-camera for all meetings with appropriate business attire and standard Slipstream virtual background.
• On occasion, some travel to client locations or company meetings may be required.
• Travel will be no more than 10%.

Physical Requirements

• This position requires the ability to remain in a stationary position, often standing or sitting for prolonged periods.
• The ability to move about to accomplish tasks.
• Adjusting or moving objects up to 20 pounds in all directions.
• Communicating verbally and written word with others to exchange information.
• Exposure to a standard office environment with average room temperatures with no adverse environmental conditions expected.

Hourly Rate

• $85/hr.-$95/hr.

Slipstream IT is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation or identity, national origin, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Slipstream IT makes hiring decisions based solely on qualifications, merit, and business needs at the time.

This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at any time at the sole discretion of the Employer.