Digital Products Quality Engineering Lead

Biopharma Careers; St. Louis (MO); On-site; USD 111,000 - 196,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Job summary

MilliporeSigma in the United States seeks a Digital Products Quality Engineering Lead to guide QA/QC for digital products in an Agile environment. You will lead a global team ensuring products meet quality and regulatory needs, including GAMP and ISO standards.

Located in Burlington or St. Louis, the role requires 10+ years in software quality roles, with expertise across QA, DevOps, and lifecycle management. Travel is possible as projects require.

Qualifications

• Ten or more years in software development, QA, and quality management.
• Experience with GMPs, GCPs, GLPs, GAMP and 21 CFR Part 11.
• Bachelor's or higher in a relevant field with willingness to travel.
• Familiar with Agile, DevOps, and software lifecycle.

Responsibilities

• Provide strategic guidance and direction for QA of digital products.
• Lead a global team to ensure products meet quality and regulatory standards.
• Promote built-in quality and shift-left practices across product teams.

Skills

Software quality leadership

QA management

Agile / DevOps

Regulatory compliance

GAMP 5

ISO standards

Life science knowledge

Team mentoring

Education

Bachelor’s or higher in CS/Engineering

Tools

CSA - Computer Software Assurance

Cloud platforms

CI/CD

Job description

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

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. Louis

Who 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:

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 here .

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!