Digital Products Quality Engineering Lead
About The Position
The 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 an Agile framework. This role involves leading a team of software quality engineers to ensure digital products meet quality standards, enabling end customers to meet their quality and regulatory/validation needs. The lead will collaborate with cross-functional global teams, promote built-in quality and shift-left practices, and enable software quality engineers to achieve digital product quality objectives. Responsibilities include end-to-end quality assurance and control, applying 4-eye principles, managing escalations, problem-solving, and fostering a collaborative, high-performance culture. Familiarity with industry standards like GAMP 5 and relevant Software ISO standards, as well as understanding customer quality expectations in regulated life-science environments, is crucial.
Requirements
- 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.
- 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.
- Experience in building and developing team competency/management.
- Experience with cloud-based platforms.
- Proven track record in shaping digital product's quality engineering.
- Proven track record in converting challenges into actions to enable faster Go-to-Market Transformation.
- Proven track record in software operational controls (change, incident, audit support, questionnaire, supplier quality, periodic review, deviations).
- Proven track record in Continuous Integration and Continuous Delivery software development.
- Ability to communicate with clarity.
- Ability to influence software engineering team's quality mindset.
- Hands-on experience in establishing software development processes and its continuous improvement, workflows, templates.
- Hands-on experience in defining/monitoring key quality indicators.
- Hands-on experience in mentoring quality assurance/control team members.
- Hands-on experience in design reviews/verification.
- Hands-on experience in review of software engineering artifacts (specifications, code/objects, test scripts, executions evidence).
- Hands-on experience in product engineering traceability.
- Hands-on experience in defect management and corrective/preventive management.
- 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.
- Experienced in digital product development/lifecycle artifact’s inspection readiness.
- Experienced in facilitating quality/product audits/inspections.
- 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.
Nice To Haves
- Implementation experience of CSA-Computer Software Assurance is a plus.
- Life regulated industry experience is a plus.
- 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.
Responsibilities
- Provide strategic guidance and direction for quality assurance and quality control of digital products developed/maintained following Agile framework.
- Lead a team of software quality engineers to ensure digital products meet quality standards.
- Enable end customers to meet their quality and regulatory/validation needs.
- Work with cross-functional global teams in various disciplines.
- Promote built-in quality and shift-left practices.
- Enable continuous verification.
- Enable software quality engineers to meet the quality objectives of digital products.
- Manage end-to-end quality assurance and quality control activities for digital products.
- Apply 4-eye principles.
- Manage escalations.
- Solve problems promptly.
- Foster a collaborative, high-performance culture.
- Ensure digital product quality meets customer expectations, quality promises, and compliance with required/applicable science regulations, industry standards/benchmark guidance.
- Facilitate quality/product audits/inspections.
Benefits
- health insurance
- paid time off (PTO)
- retirement contributions
- other perquisites
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What This Job Offers
Job Type
Full-time
Career Level
Manager
