Senior Analyst – GxP IT QA/CSV

This is a fully remote position, open to applicants in California, +2 more states.

📋 Description

• Lead and oversee IT compliance and quality initiatives.

• Engage with clients on IT compliance projects, focusing on regulations such as FDA, EU EMA, and other global health authority guidelines, as well as privacy laws like GDPR and CCPA, or CAP/CLIA regulations.

• Manage the complete lifecycle of IT compliance projects, starting from initial assessments and requirements gathering to implementation, validation, and post-implementation support.

• This encompasses Computer Systems Validation (CSV) and importantly, the adoption of modern methodologies for Computer Software Assurance (CSA) in accordance with FDA guidelines and GAMP 5.

• Facilitate technical discussions, document key compliance resolutions, and monitor action items.

• Ensure that projects meet client expectations, are completed punctually, and comply with relevant regulations and industry best practices (including 21 CFR Part 11 and EU Annex 11), focusing on true risk-based validation strategies.

• Maintain a personal billable utilization target of 1700 hours annually.

• Develop client deliverables centered around compliance.

• Create high-quality, client-ready outputs that effectively communicate intricate IT compliance requirements and solutions in a clear and compelling manner.

• Employ advanced skills in Excel and PowerPoint to create detailed compliance roadmaps, IT strategy documents, system validation plans, and risk assessments.

• Design technology presentations and reports that convey business value and illustrate how proposed solutions will tackle client compliance challenges, enhance data integrity, and reduce risks.

• Develop Policies, Procedures, Forms, and Templates to promote regulatory compliance within the IT sector.

• Generate formal systems validation documentation (e.g., Validation Plans, Requirements/Specifications, Risk Assessments, Test Plans, Trace Matrices, etc.).

• Assist clients in modernizing and improving their IT compliance approaches.

• Lead data collection, IT analysis, and assessments pertaining to IT compliance and Data Integrity.

• Take the initiative in gathering data and performing analyses to comprehend and address client compliance issues.

• Conduct system audits, evaluate IT systems for compliance gaps, assess data integrity risks, and pinpoint opportunities for compliance enhancement and automation.

• Support customers in evaluating and/or implementing technologies that automate compliance tasks, including ALM/VLM solutions or automated testing software, as well as ITSM solutions for managing change control.

• Design technology solutions and architectures that adhere to regulatory requirements and integrate best practices for data governance and security.

• Develop advanced models for assessing IT compliance, cost structures, and risk mitigation.

• Experience in the qualification and/or validation of both on-premises and cloud-based infrastructure and applications, including SaaS.

• Manage and convey complex IT compliance concepts to both technical and non-technical audiences, which is vital for project success and ensuring client expectations are consistently met or surpassed.

• Actively engage in business development efforts by identifying IT compliance opportunities within existing client relationships and aiding in the acquisition of new clients.

• Perform compliance assessments, draft proposals for IT compliance solutions, and contribute to the firm’s reputation as a leader in IT compliance within the life sciences sector.

• Cultivate relationships with senior IT and Quality executives and influence key decision-makers; this will be essential in driving revenue growth and expanding the firm’s IT compliance consulting services.

⛳️ Requirements

• 3 to 5+ years of consulting experience or equivalent work experience in IT compliance within the life sciences sector.

• Familiarity with 2 or more regulated life science domains such as GCP, GMP, GLP, GDP, PV, etc.

• Experience with IT compliance or CSV in at least 2 to 3 life science functions (e.g., Medical Device software, Clinical, Quality, Supply Chain/Manufacturing, Pharmacovigilance, Labs, etc.).

• Proficiency with several leading software brands commonly used in life sciences (such as SAS, Veeva, TrackWise, MasterControl, Medidata, ZenQMS, Labvantage, Labware, Sapio, Benchling, Blue Mountain, BatchMaster, SAP, NetSuite, MS Dynamics, etc.).

• Experience in qualifying infrastructure for GxP use is a plus.

• Familiarity 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-driven environment.

• Proven capability to design and implement solutions that enhance compliance, mitigate risk, and deliver business value.

• Extensive understanding of regulations and standards pertinent 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 applicable to automated business processes.

• Familiarity with EU EMA regulations relevant to automated business processes.

• Knowledge of Data Integrity principles including ALCOA+.

• Experience with the validation of Software in or as Medical Devices is an advantage.

• Exceptional verbal and written communication skills, with the ability to present complex compliance concepts to senior-level stakeholders.

• Strong analytical capabilities, with the proficiency to assess technical systems and recommend enhancements that improve compliance and data integrity while considering business needs.

• Experience contributing to business development activities, including proposal development, building robust client relationships, and identifying new IT compliance service opportunities.

🏝️ Benefits

• Health insurance

• Remote work options

• Professional development opportunities