Establish and lead the QA/QC function by designing test plans, managing defects, and ensuring release readiness for the product portfolio. Implement rigorous validation practices, including Computer Systems Validation (CSV), to support clients in regulated life sciences environments.
QA/QC Lead
What You'll Do
As our QA/QC Lead, you will establish a more formal quality function for Vaniam’s product portfolio. This is a hands-on individual contributor role today, with the opportunity to grow into a broader lead role as the function scales.
You will own the practical testing discipline needed to support high-quality releases: test plans, manual and automated testing, UAT scripts, defect management, traceability, and release readiness. You will also bring the rigor required for clients operating in regulated life sciences environments, including experience with Computer Systems Validation (CSV) or closely related validation practices.
The right candidate is not only a quality thinker, but a doer — someone comfortable building the function while executing the work.
A Day In the Life
Deliverables
- Design, document, and execute test plans for new features, enhancements, configurations, integrations, and releases.
- Build a pragmatic automation strategy that balances automated regression coverage with hands-on testing where human judgment is required.
- Create and maintain UAT scripts that are clear enough for business users and clients to execute consistently.
- Build and maintain traceability matrices linking requirements, user stories, test cases, defects, and outcomes.
- Support CSV activities, including validation planning, evidence capture, test documentation, deviation handling, and audit-ready records where applicable.
- Define practical quality gates for feature completion, UAT readiness, production release, and post-release monitoring.
- Develop quality metrics that help the team understand defect trends, test coverage, release readiness, and recurring root causes.
Client Responsibilities
- Support client-facing UAT activities when needed, including approximately 10% client interaction for UAT preparation, execution, or follow-up.
Internal Responsibilities
- Perform hands-on functional, regression, usability, data integrity, and exploratory testing across product workflows.
- Develop clear acceptance criteria and testing coverage in partnership with Product, Engineering, Technical Project Management, and Client Delivery.
- Identify, document, prioritize, and track defects through resolution, retest, and release readiness.
- Use tools and frameworks such as Selenium, Playwright, Cypress, Postman, Jira/Xray, Zephyr, TestRail, or similar platforms as appropriate for Vaniam’s environment.
- Use approved AI tools to accelerate test case generation, edge-case identification, script drafting, regression planning, defect summarization, and documentation review.
- Continuously identify ways to improve test coverage, reduce repetitive manual effort, and strengthen release confidence.
- Partner with Technical Project Management to ensure QA timelines, dependencies, and risks are visible in release plans.
- Help create a quality-driven culture in which defects, gaps, and risks are surfaced early and resolved constructively.
YEAR ONE PRIORITIES
- Stand up the core QA/QC operating model, including test planning standards, defect workflows, UAT templates, and release readiness criteria.
- Create a scalable approach to traceability across requirements, test cases, defects, and validation evidence.
- Establish a practical regression testing model that combines automated and manual coverage.
- Improve the consistency and confidence of product releases before client exposure.
- Define how CSV support should operate across Vaniam’s product delivery model, including documentation expectations and audit-readiness practices.
WHAT YOU HAVE
Education and experience
- 5–8+ years of hands-on QA, software testing, validation, or quality engineering experience.
- Experience testing software products, web applications, data platforms, CRM-like systems, analytics platforms, or configuration-heavy environments.
- Experience creating test plans, test cases, defect reports, UAT scripts, regression suites, and release readiness documentation.
- Experience operating in healthcare, life sciences, pharmaceutical, medical communications, or another regulated environment is strongly preferred.
Skills and competencies
- Strong knowledge of software QA methodologies, SDLC practices, defect management, and test documentation.
- Hands-on experience with both manual testing and automated testing approaches.
- Working knowledge of test management and defect tracking tools such as Jira, Xray, Zephyr, TestRail, Azure DevOps, or similar systems.
- Ability to understand business requirements, technical specifications, and user workflows — then convert them into strong test coverage.
- Strong attention to detail, analytical thinking, and clear written documentation.
Strongly preferred
- Experience with Computer Systems Validation (CSV), including IQ/OQ/PQ concepts, traceability, validation evidence, deviations, and audit readiness.
- Experience building or improving a QA function in a growing product organization.
- Experience with automated testing frameworks such as Selenium, Playwright, Cypress, or similar tools.
- Experience using AI tools to strengthen test coverage, documentation, and QA efficiency.
THE TEAM YOU’LL WORK CLOSEST WITH
You will work closely with Product Management, Engineering, Technical Project Management, Client Delivery, Client Services, and external development partners. You will report to the VP, Product Management and serve as the primary quality owner for product release confidence.
Why You’ll Love Us:
- 100% remote environment with opportunities for local meet-ups
- Positive, diverse, and supportive culture
- Passionate about serving clients focused on Cancer and Blood diseases
- Investment in you with opportunities for professional growth and personal development through Vaniam Group University
- Health benefits – medical, dental, vision
- Generous parental leave benefit
- Focused on your financial future with a 401(k) Plan and company match
- Work-Life Balance and Flexibility
- Flexible Time Off policy for rest and relaxation
- Volunteer Time Off for community involvement
- Emphasis on Personal Wellness
- Virtual workout classes
- Discounts on tickets, events, hotels, child care, groceries, etc.
- Employee Assistance Programs
Salary offers are based upon several factors including experience, education, skills, training, demonstrated qualifications, location, and organizational need. The range for this role is $120,000 to $135,000. Salary is one component of the total earnings and rewards package offered.
About Us:
Vaniam Group is a people-first, purpose-driven, independent network of healthcare and scientific communications agencies committed to helping biopharmaceutical companies realize the full potential of their compounds in the oncology and hematology marketplace. Founded in 2007 as a virtual-by-design organization, Vaniam Group harnesses the talents and expertise of team members around the world. For more information, visit www.VaniamGroup.com.
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