Senior Analyst – GxP IT QA/CSV

Role Overview

• Lead and manage IT compliance and quality projects
• Deliver client engagements focused on IT compliance, including but not limited to FDA, EU EMA, and other global health authority regulations, privacy regulations (GDPR, CCPA, etc.) or CAP/CLIA regulations.
• Oversee the end-to-end lifecycle of IT compliance projects, from initial assessment and requirements gathering to implementation, validation, and post-implementation support.
• This includes Computer Systems Validation (CSV) and, importantly, applying modern approaches to Computer Software Assurance (CSA) per FDA guidance and GAMP 5.
• Lead technical discussions, document key compliance decisions, and track action items.
• Ensure that projects meet client expectations, are completed on time, and align with relevant regulations and industry best practices (including 21 CFR Part 11, EU Annex 11), emphasizing true risk-based approaches to validation.
• Maintain personal billable utilization at the rate of 1700 hours per year.
• Develop compliance-focused client deliverables.
• Create high-quality, client-ready deliverables that communicate complex IT compliance requirements and solutions in a clear and compelling way.
• Utilize advanced skills in Excel and PowerPoint to develop detailed compliance roadmaps, IT strategy documents, system validation plans, and risk assessments.
• Design technology presentations and reports that articulate business value and demonstrate how the proposed solutions will address client compliance challenges, improve data integrity, and mitigate risks.
• Develop Policies, Procedures, Forms, and Templates to drive regulatory compliance in the IT domain.
• Develop formal systems validation documentation (eg Validation Plans, Requirements/Specifications, Risk Assessments, Test Plans, Trace Matrices etc.)
• Assist clients to improve and modernize their approaches to IT compliance
• Lead data collection, IT analysis, and assessments related to IT compliance and Data Integrity.
• Take the lead in gathering data and conducting analyses to understand and remediate client compliance challenges.
• Conduct system audits, evaluate IT systems for compliance gaps, assess data integrity risks, and identify opportunities for compliance improvement and automation.
• Assist customers to evaluate and/or implement technologies that automate compliance tasks, including ALM/VLM solutions or automated testing software, as well as ITSM solutions to manage change control.
• Design technology solutions and architectures that meet regulatory requirements and incorporate best practices for data governance and security.
• Develop sophisticated models for assessing IT compliance, cost structures, and risk mitigation.
• Experience with qualification and/or validation of on-premises and cloud-based infrastructure and applications, including SaaS.
• Manage and communicate complex IT compliance concepts to both technical and non-technical audiences; this will be critical to driving project success and ensuring that client expectations are consistently met or exceeded.
• Actively contribute to business development activities by identifying IT compliance opportunities within existing client relationships and helping to acquire new clients.
• Conduct compliance assessments, prepare proposals for IT compliance solutions, and contribute to the firm’s position as a leader in IT compliance within the life sciences industry.
• Foster relationships with senior IT and Quality executives and influence decision-makers; this will be crucial to driving revenue growth and expanding the firm’s IT compliance consulting offerings.

Requirements

• 3 to 5+ years of consulting experience or equivalent work experience in IT compliance within the life sciences industry.
• Experience in 2 or more regulated life science domains eg GCP, GMP, GLP, GDP, PV etc.
• Experience with IT compliance or CSV in at least 2 to 3 life science functions (eg. Medical Device software, Clinical, Quality, Supply Chain/Manufacturing, Pharmacovigilance, Labs etc).
• Experience with several leading software brands used extensively in life sciences (such as SAS, Veeva, TrackWise, MasterControl, Medidata, ZenQMS, Labvantage, Labware, Sapio, Benchling, Blue Mountain, BatchMaster, SAP, NetSuite, MS Dynamics etc.).
• Experience with qualification of infrastructure for GxP use is an advantage.
• Experience with Lab systems is an advantage.
• Bachelor’s degree in a relevant field (e.g., Computer Science, Information Systems, or a Life Sciences discipline).
• Leadership skills with experience managing IT or Quality teams and mentoring junior staff in a compliance-focused environment.
• Proven ability to design and implement solutions that drive compliance, mitigate risk, and provide business value.
• Deep understanding of regulations and standards relevant to the life sciences industry at the intersections of Technology, Quality, Privacy and Compliance including but not limited to: 21 CFR Part 11 EU Annex 11 GAMP 5 SDLC and custom software development Computer Systems Validation (CSV), Computer Software Assurance (CSA) and modern validation methodologies.
• Familiarity with FDA regulations, as applicable to automated business processes.
• Familiarity with EU EMA regulations, as applicable to automated business processes.
• Data Integrity including ALCOA+.
• Experience with validation of Software in or as Medical Devices is a plus.
• Exceptional verbal and written communication skills, with the ability to present complex compliance concepts to senior-level stakeholders.
• Strong analytical skills, with the ability to evaluate technical systems and recommend improvements that enhance compliance and data integrity, while considering business needs.
• Experience in contributing to business development activities, including proposal framing, building strong client relationships, and identifying new IT compliance service opportunities.

Tech Stack

• Cloud
• Google Cloud Platform
• ITSM
• SDLC

Benefits

• Health insurance
• Remote work options
• Professional development opportunities