Sr. Software Quality Assurance - SME

United Pharma; Chicago (IL); On-site; USD 110,000 - 150,000; Full time

Job summary

United Pharma seeks a Software QA professional with SDLC validation experience to lead review and approval of regulated IT deliverables. The role focuses on MVPs, risk assessments, IQ/OQ/PQ, trace matrices, and system release with emphasis on CAPA, change control, and defect management in a compliant GMP/GLP context.

The candidate should excel in collaboration with development teams, ensuring continuous improvement of validation strategies and clear regulatory guidance across projects.

Qualifications

• Experience validating SDLC deliverables (MVP, Risk Assessment/FMEA, Requirements, IQ, OQ, PQ, Trace Matrix, System Release)
• Review and approve SDLC deliverables and CAPAs/Change Controls/Defects as they apply to software validation
• Strong understanding of GxP regulations and validation principles
• Experience with automated testing and CI tools is a plus
• Excellent written and verbal English communication in regulated environments

Responsibilities

• Ensure IT validation packages are inspection ready and compliant with company policies
• Lead in Review and Approval of regulated IT applications
• Collaborate with development teams to build compliance capabilities for high-quality deliverables
• Support validation strategy for IT changes and process improvements
• Communicate regulatory guidance to project teams

Skills

SDLC validation

Regulatory compliance

Analytical thinking

Effective communication

Risk management

Tools

JIRA

Confluence

HPALM

Tosca

Qtest

MFiles

Job description

Required: Software Quality Assurance with Review and Approval Experience for SDLC Deliverables

Experience should have earlier in career in SDLC/Software Validation with writing and execution of SDLC deliverables (e.g. MVP, Risk Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix, and System Release).

Several years of SQA experience with Review and Approval of SDLC deliverables (e.g. MVP, Risk Assessment (FMEA)

Requirements, IQ, OQ, PQ, Trace Matrix and writing of System Certification)

Also, should have good experience in Review of CAPA’s, Change Control and Defects as it applies to Software Validation while concurrently having good soft skills such as a good and effective communicator and vocal during meeting and projects.

Experience with Multiple Tools/applications such as but not limited to JIRA, Confluence, HPALM, Tosca, Confluence, Veera, Qtest, MFiles, Microsoft Teams and other tools such as the following are a plus: Data Lake, AWS, Databricks, Github, or

other continuous integration tools

Main Responsibilities

• Strong Validation Resource with 10+ yrs Experience Responsibilities
• Ensure IT validation packages are inspection ready and in compliance with applicable company policies and procedures.
• Work autonomously with related IT contacts and the business process SMEs for this purpose.
• Support as SQA in the Review and Approval and implementation of regulated IT applications.
• Ensure continuous improvement and gives input related to the validation strategy for IT changes.
• Collaborate with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensures business needs are met.

Requirements

• Must have previous experience validating systems
• Proficient in understanding of GxP regulations and validation principles
• Strong analytical skills with the ability to organize work in a logical, thorough and succinct manner.
• Highly self-motivated, self-directed
• Understanding of risk management principles, regulatory requirements and, industry best practices.
• Knows the difference between Waterfall and Agile software development methodologies
• Previous experience with automated testing and implementation
• Familiarity with a range of applications/tools including JIRA, Confluence, HP-ALM, Tosca, Confluence, Veera ,Qtest, M Files, or other continuous integration tools
• Effective with written and verbal in English communications at all levels, providing input and regulatory guidance to project teams
• Role must maintain compliance expertise and be effective at applying requirements in the IT and business environment that supports business goals and maintaining a compliant state.