Your Role:Digital Products Quality Engineering Lead is responsible for the strategic guidance and direction of quality assurance and quality control of digital products developed / maintained following Agile framework. You will lead a team of software quality engineers to ensure the digital products meet the quality standards that will enable the end customers to meet their quality and regulatory/validation needs. You will work with cross-functional global teams in various disciplines, promote built-in quality, shift-left practices, continuous verification and enable the software quality engineers to meet the quality objectives of digital products. You are responsible for end-to-end quality assurance and quality control activities for digital products, applying 4 eye principles, managing escalations, solving problems promptly, and fostering a collaborative, high-performance culture.
You are familiar with relevant industry standards and guidance, including GAMP 5 supplier-focused principles and applicable Software related ISO standards, and understand the quality expectations of customers in regulated life-science environments
Can be located in Burlington or St. LouisWho You Are:- You bring 10+ years of combined experience as manager/supervisor level managing; software development / engineering, digital transformation, software quality assurance / control, software quality management, proficiency in life science / pharma regulations/ industry standards / related ISO standards.
- You have a strong command in software product life cycle, change management, agile ways of product development, DevOps, Lean, Plan-Do-Check-Act, software test automation, risk-based quality management systems, building and developing the team competency/management, cloud-based platforms, implementation experience of CSA-Computer Software Assurance is a plus.
- You have a proven track record in, shaping digital product's quality engineering, converting challenges into actions to enable faster Go-to-Market Transformation, software operational controls (change, incident, audit support, questionnaire, supplier quality, periodic review, deviations), Continuous Integration and Continuous Delivery software development, communicate with clarity, able to influence software engineering team's quality mindset.
- You bring hands on experience in, establishing software development processes and its continuous improvement, workflows, template, defining / monitoring key quality indicators, mentoring quality assurance/control team members, design reviews/verification, review of software engineering artifacts (specifications, code/objects, test scripts, executions evidence), product engineering traceability, defect management and corrective/preventive management.
- You are experienced in ensuring digital product quality meets customer expectations, quality promises, compliance with required/applicable science regulations, industry standards/ benchmark guidance, including GAMP 5 supplier focused principles, related ISO standards, digital product development/lifecycle artifact's inspection readiness, facilitating quality/product audits / inspections, life regulated industry is a plus.
- Bachelor's or higher degree in Computer Science, Engineering disciplines, Information/ Operational Technology, Digital and Data management or Information Science / Management, Bio-Medical Science, or other Life Science disciplines. Willingness to travel globally based on the need of project and business.
Minimum Qualifications:Bachelor's or higher degree in Computer Science, Engineering disciplines, Information/ Operational Technology, Digital and Data management or Information Science / Management, Bio-Medical Science, or other Life Science disciplines.
10+ years of combined experience in software development / engineering, digital transformation, software quality assurance / control, software quality management, proficiency in life science / pharma regulations/ industry standards / related ISO standards.
Preferred Qualifications:Good written and verbal skills.
Excellent computer skills, i.e., Project Planning, Word, Excel, PowerPoint, SharePoint.
Experience with GMPs, GCPs, GLPs, GAMP and Part 11 compliance
Global travel based on the need of project and business.
Pay Range for this position: $111,400-$196,000
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click
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