SUMMARY:
The Director of Software Quality Assurance (QA) will lead the design and implementation of quality assurance policies and procedures at Baylor Genetics, including QA for full-stack software systems as well as bioinformatics analysis pipelines. This role involves collaborating with cross-functional teams, including product managers, software engineers, scientists, and clinical reviewers, to ensure the efficient implementation of QA best practices across all platforms. Additionally, this role will ensure that the software systems meet regulatory compliance standards such as those of CLIA, CAP, HIPAA, and the FDA. Your work will be critical in the development of quality healthcare and analytical products that will impact patients across the globe.
RESPONSIBILITIES:
Implementation of Quality Assurance Best Practices:
- Establish QA processes that adhere to best practices and methodologies within a healthcare environment.
- Oversee the implementation of automated QA processes for CI/CD pipelines within an agile framework, working with Software and DevOps teams to ensure smooth product delivery.
- Ensure the excellence of software testing through automated build and deployment processes with integration, regression, and end-to-end tests.
QA Systems Design:
- Design QA processes and workflows for testing full-stack software products across multiple platforms.
- Oversee the development of automated QA systems for testing bioinformatics pipelines within the context of Linux environments.
- Define and document systems and processes related to software testing and clinical validations.
Strategic Department and Team Leadership:
- Collaborate with cross-functional teams to design, develop, and execute quality assurance products that meet stakeholder needs both externally and internally.
- Provide strong leadership and mentorship of diverse QA teams responsible for the testing of an array of software and analytical products.
- Oversee QA training infrastructure and implementation.
Regulatory Compliance:
- Ensure that software and analytical products meet regulatory standards, such as those for CAP, CLIA, HIPAA, and the FDA.
- Oversee testing of bioinformatics pipelines for the assurance of meeting analytical standards such as sensitivity, specificity, and accuracy.
- Work closely with quality management and compliance departments to investigate and document QA processes to ensure regulatory compliance.
QUALIFICATIONS:
Skills:
- Deep knowledge of QA best practices and methodologies.
- Demonstrated proficiency in standard industry tools for QA and QA automation.
- Strong written and verbal communication skills.
- Knowledge of bioinformatics software for next-generation sequencing workflows and analytical performance evaluation (sensitivity, specificity, PPV, NPV, etc.) a plus.
- Experience with Jira, Confluence, and Agile methodologies a plus.
Education:
- Bachelor’s degree or higher in computer science, bioinformatics, or related field.
Experience:
- 8+ years of experience in quality assurance.
- 5+ years in the leadership of quality assurance teams.
- Experience in healthcare-related environments with high regulatory requirements.
Physical Demands and Work Environment:
- Frequently required to sit.
- Frequently required to stand.
- Frequently required to utilize hand and finger dexterity.
- Frequently required to talk or hear.
EEO Statement:
Baylor Genetics is proud to be an equal opportunity employer dedicated to building an inclusive and diverse workforce. We do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, gender identity, veteran status, disability, genetic information, pregnancy, childbirth, or related medical conditions, or any other status protected under applicable federal, state, or local law.
