Senior IT Quality & Compliance Analyst (CSV/CSA)

Creo Inc; United States; Remote; USD 140,000 - 180,000; Full time

Job summary

Creo Inc is seeking a Senior IT Quality and Compliance Analyst to lead client engagements in IT compliance, CSV, and CSA across the life sciences sector. The role supports regulatory programs including FDA and EU requirements and will serve clients nationally, preferably from Boston, MA, or RTP.

You will own workstreams, deliver high-quality validation deliverables, and help modernize IT compliance while communicating complex concepts to technical and non-technical audiences.

Qualifications

• 3 to 5+ years of consulting experience in IT compliance within life sciences.
• Experience in 2 or more regulated life science domains (GCP, GMP, GLP, GDP, PV).
• Experience with IT compliance or CSV in 2–3 life science functions (e.g., Medical Device software, Clinical, Quality, Supply Chain/Manufacturing, Pharmacovigilance, Labs).
• Familiarity with leading software brands used in life sciences (SAS, Veeva, TrackWise, MasterControl, Medidata, ZenQMS, Labvantage, Labware, Sapio, Benchling, Blue Mountain, BatchMaster, SAP, NetSuite, MS Dynamics).
• Understanding of qualification of infrastructure for GxP use is an asset.
• Bachelor’s degree in a relevant field (e.g., Computer Science, Information Systems, Life Sciences).
• Strong ability to design and implement compliant, value-driving solutions.
• In-depth knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, SDLC, CSV and CSA concepts.

Responsibilities

• Lead IT compliance projects including FDA, EU EMA regulations, privacy rules, and CAP/CLIA requirements.
• Oversee end-to-end project lifecycle from assessment to validation and post-implementation support.
• Develop client-ready deliverables and risk assessments using Excel and PowerPoint.
• Create validation documentation such as Validation Plans, Requirements, Trace Matrices, and Test Plans.
• Identify opportunities for compliance improvement, automation, and data governance.
• Support business development through proposals and client relationships.

Skills

IT compliance

Regulatory knowledge

Analytical skills

Communication

Project management

Education

Bachelor’s degree in a relevant field

Tools

SAS

Veeva

TrackWise

MasterControl

Medidata

ZenQMS

Labvantage

Labware

Sapio

Benchling

Blue Mountain

BatchMaster

SAP

NetSuite

MS Dynamics

Job description

Creo Inc is seeking a Senior IT Quality and Compliance Analyst to lead client engagements in IT compliance, CSV, and CSA across the life sciences sector. The role supports regulatory programs including FDA and EU requirements and will serve clients nationally, preferably from Boston, MA, or RTP.

You will own workstreams, deliver high-quality validation deliverables, and help modernize IT compliance while communicating complex concepts to technical and non-technical audiences.