Manager-IT Quality

Job Description

Job Description

Salary:

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

• Bachelors 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