Digital Products Quality Engineering Lead

Merck•Saint Louis, MO

5d•Hybrid

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 or 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 product quality objectives. Responsibilities include end-to-end quality assurance and control, applying the 4-eye principle, managing escalations, problem-solving, and fostering a high-performance culture. Familiarity with industry standards like GAMP 5 and relevant ISO standards, as well as understanding 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, and software quality management.
Proficiency in life science/pharma regulations, industry standards, and related ISO standards.
Strong command in software product life cycle, change management, agile product development, DevOps, Lean, Plan-Do-Check-Act, software test automation, and 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 quality engineering.
Proven track record in converting challenges into actions for faster Go-to-Market Transformation.
Experience with software operational controls (change, incident, audit support, questionnaire, supplier quality, periodic review, deviations).
Experience with Continuous Integration and Continuous Delivery software development.
Ability to communicate with clarity and influence software engineering teams' quality mindset.
Hands-on experience in establishing software development processes and their continuous improvement, workflows, and 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 reviewing 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.
Experience in ensuring digital product quality meets customer expectations, quality promises, and compliance with required/applicable science regulations, industry standards/benchmark guidance, including GAMP 5 supplier focused principles, and related ISO standards.
Experience in digital product development/lifecycle artifact inspection readiness.
Experience 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.
Good written and verbal skills.
Excellent computer skills, i.e., Project Planning, Word, Excel, PowerPoint, SharePoint.

Nice To Haves

Implementation experience of CSA-Computer Software Assurance is a plus.
Life regulated industry experience is a plus.
Experience with GMPs, GCPs, GLPs, GAMP and Part 11 compliance.
Global travel based on the need of project and business.

Responsibilities

Provide strategic guidance and direction for quality assurance and quality control of digital products.
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.
Ensure software quality engineers 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 and solve problems promptly.
Foster a collaborative, high-performance culture.
Ensure digital product quality meets customer expectations and quality promises.
Ensure compliance with required/applicable science regulations, industry standards/benchmark guidance, including GAMP 5 supplier focused principles, and related ISO standards.
Ensure digital product development/lifecycle artifacts are inspection-ready.
Facilitate quality/product audits/inspections.
Establish software development processes and their continuous improvement, workflows, and templates.
Define and monitor key quality indicators.
Mentor quality assurance/control team members.
Conduct design reviews/verification.
Review software engineering artifacts (specifications, code/objects, test scripts, execution evidence).
Ensure product engineering traceability.
Manage defects and implement corrective/preventive actions.