Purpose
We are seeking an experienced IT Quality Manager to lead and oversee the quality assurance efforts for our IT products and services, including both off-the-shelf solutions and custom-developed applications. This role is critical in ensuring that all IT deliverables meet established quality standards, comply with regulatory requirements, and exceed customer expectations.
The ideal candidate will have a strong background in quality management within regulated environments (e.g., healthcare, pharmaceuticals, finance), A key responsibility of this role is to partner closely with existing Quality Management teams across our various divisions, ensuring alignment and collaboration with enterprise-wide quality initiatives, with a specific focus on information technology.
Responsibilities
- Develop, implement, and maintain a comprehensive IT Quality Management System (QMS) aligned with regulatory standards (e.g., FDA, GxP, SOX, ISO 9001)
- Define and enforce quality assurance policies, procedures, and best practices across IT projects and operations
- Partner with divisional Quality Management teams to ensure IT quality practices are integrated with broader organizational quality goals and regulatory compliance efforts
- Oversee testing strategies for software applications (COTS and custom), including functional, regression, integration, and user acceptance testing (UAT)
- Collaborate with development, infrastructure, cybersecurity, and business teams to ensure quality is embedded throughout Computer System Validation (CSV) and the software development lifecycle (SDLC)
- Lead risk assessments, root cause analyses, and corrective/preventive actions (CAPA) for IT-related issues
- Ensure compliance with internal and external audits, and support audit readiness and response activities
- Monitor and report on quality metrics, KPIs, and continuous improvement initiatives
Qualifications/Requirements
- Bachelor’s degree in Computer Science, Information Systems, Engineering, or a related field
- 5+ years of experience in IT quality assurance or quality management, with at least 3 years in a regulated industry
- Strong knowledge of regulatory frameworks (e.g., FDA 21 CFR Part 11, GAMP 5, HIPAA, SOX)
- Experience working with Quality Management Systems (QMS) and Learning Management Systems (LMS) in support of compliance and training initiatives
- Experience with QA tools (e.g., Jira, TestRail, Selenium, HP ALM) and automated testing frameworks
- Familiarity with Agile, DevOps, and Waterfall methodologies
- Excellent analytical, problem-solving, and communication skills
Preferred Qualifications
- Detail-oriented with a passion for quality and continuous improvement
- Strong leadership and stakeholder management skills
- Ability to work independently and manage multiple priorities in a fast-paced environment
