• Build, own, and continuously improve Loyal's CMC quality management system: SOPs, document control, change control, deviation management, CAPA, and risk management processes; ensure systems are fit for purpose now and scalable through commercial launch • Serve as the primary QA point of contact for CDMOs, contract testing laboratories, and key raw material and excipient suppliers, lead qualification, audit execution, and ongoing quality oversight of all external partners • Negotiate, draft, and maintain quality agreements with CDMOs and contract testing laboratories; drive timely execution and hold partners accountable to commitments • Plan and conduct routine GMP audits of CDMOs and suppliers; own audit finding responses and track CAPAs to closure • Lead batch disposition decisions for clinical and development batches; ensure complete, audit-ready documentation packages and timely release • Review and approve analytical method validation protocols and reports, stability protocols and data, executed batch records, CoAs, and CoCs • Oversee deviation and OOS management originating from external partners through to closure • Execute PAI readiness activities including quality systems documentation, validation packages, and site readiness; serve as QA lead during FDA inspections and agency interactions related to CMC • Partner with Regulatory Affairs and CMC teams to ensure quality considerations are incorporated into program decisions, technical transfers, and filing activities; support QA input into NDA and other regulatory submissions • Provide QA oversight of all tech transfer activities — site qualification, process comparability, transfer protocols, and batch record development • Own the Annual Product Review (APR/PQR) process and QA sign-off on labeling for clinical and commercial supply • Define, track, and report CMC QA KPIs: CDMO performance, CAPA cycle times, deviation trends, audit findings, quality agreement status, and batch disposition timelines; use metrics to drive external partner accountability and surface risks proactively to leadership • Apply formal quality risk management principles (ICH Q9) across manufacturing and development activities • Build quality infrastructure that supports the transition from clinical to commercial supply, including commercial batch release processes, post-approval change management, and commercial QMS requirements • Balance compliance requirements with the practical realities of a fast-moving startup environment

• Design and implement a scalable, maintainable test automation framework. • Evaluate and integrate emerging technologies, specifically focusing on Agentic AI-powered solutions and GenAI. • Partner with Development and Product teams to ensure testability is considered at the architectural level. • Act as a hands-on mentor, conducting 1:1s, leading code reviews for automation scripts, and fostering professional growth. • From functional and regression to performance and security testing, ensure CI/CD pipelines are robust. • Analyze test results and system architectures to provide stakeholders with clear quality metrics and actionable data.

Role Description Designs, develops, and implements testing methods and equipment to ensure that the product will perform to specifications. The candidate will use technical expertise on IT products and will work with developers, end users, and organizations to: - Create test plans and test scripts. - Coordinate with test sites and other team participants to plan test events. - Develop testing procedures, test plans, scripts, scenarios, functional tests, regression tests, and deployment tests. - Implement the testing processes and ensure all test activities follow those processes. - Produce reports on each test activity and track test metrics. - Monitor for continual test process improvement through failure analysis, throughput analysis, yield analysis, and report to management periodically. Qualifications - Bachelor’s degree in engineering, or a related scientific or technical discipline plus 10 years of experience. 8 years of additional relevant experience may be substituted for education. - Experience in the software development lifecycle. - Experience testing Graphical User Interface (GUI) applications, Section 508 and Veterans Health Information Systems and Technology Architecture (VistA). - Proficient with MS Office (Word, Excel, PowerPoint, Visio). - Proficient with MS SharePoint and MS Teams. - Experience using Jira in an Agile or SAFe environment. - Demonstrated experience in a remote work environment. - Great interpersonal skills and ability to work independently with minimal guidance/supervision. Requirements - Experience in supporting the Department of Veterans Affairs and/or other Federal Agencies. - Well-versed in the VA project management methodology and other VA-related reporting methodologies. - Experience in VA Pharmacy. - Willingness and ability to quickly learn new skills, new client environments, and grow domain expertise. - Ability to work in a fast-paced, collaborative environment. - Excellent prioritization and time management skills. - Excellent attention to detail and ability to meet deadlines and stay organized. - Clearance Required: Ability to obtain and maintain a Suitability/Public Trust clearance. Company Description DPCG is an Equal Opportunity Employer committed to hiring and developing the most qualified individuals based on merit, experience, and business needs, without regard to any protected status under applicable law.

• Participate in Agile Scrum development methodology ceremonies (e.g., sprint planning, scrum, backlog refinement, defining tasks/tests, estimating LOE, testing, tracking work done, retrospective, demonstration, etc.) • Develop, maintain, and perform sprint-level manual/automated testing activities (e.g., define scenarios, develop detailed scripts/procedures, develop Cucumber Gherkin feature files and scenarios, map user story acceptance criteria to script verification points) in Jira with Xray and Cucumber BDD plug-ins • Develop and maintain automated scripts that are exercised during CI/CD builds and nightly regression test suite execution • Develop and maintain automated UI and backend (e.g., SQL, logs) scripts in a Java language-based Selenium/Cucumber/Serenity framework stored in a GitLab repository that may integrate with a Cucumber or generic test • Develop and maintain automated web service API validation scripts using Spring ToolSuite4, Rest Assured, Postman, Fiddler, and SoapUI • In collaboration with the Product Architect and/or Business Analyst, access impacts of candidate changes to the automated smoke and/or regression test suite(s) and plan accordingly • Perform full-scope static and dynamic testing of a system under test utilizing functional and non-functional testing techniques. • Perform script and/or code peer reviews to ensure compliance with program-level manual/automated testing standards, guidelines, and processes • Document and track testing activity progress during a sprint. This includes capturing execution artifacts to support that all backlog acceptance criteria have been successfully verified/validated