Manager, Software Quality Engineering (V&V)

What You’ll Be Doing

Quality, Compliance & Governance

• Own and maintain Solutions Delivery QA SOPs, ensuring alignment with GCP and regulatory standards.

• Ensure all validation deliverables are accurate, compliant, and completed on schedule.

• Participate in audits and implement corrective and preventive actions (CAPA).

Issue Resolution & Continuous Improvement

• Lead investigations and root cause analyses for defects, including post‑release issues.

• Drive continuous improvement initiatives using quality metrics to reduce defects and improve efficiency.

• Identify and implement tools, automation, and process improvements across the team.

Automation & Efficiency

• Oversee test automation efforts and ensure reusability across studies.

• Support integration of automation into delivery workflows to reduce cycle time.

Team Leadership & Operations

• Lead and develop SQE team members (onsite and offshore), including hiring, onboarding, training, and performance management.

• Assign tasks, manage productivity, resolve conflicts, and ensure compliance with training requirements.

• Run daily/weekly SQE meetings and support resource planning across global teams.

Project Ownership & Delivery

• Own test planning, test case review/execution oversight, and validation documentation for your assigned squad.

• Monitor project progress, identify risks early, and drive mitigation to maintain timelines.

• Provide clear, timely updates for Customer First calls, leadership reviews, and KPI reporting.

• Manage departmental tools such as JIRA and Jama.

What We Look For

• Bachelor’s degree in Information Technology, Computer Science, Engineering, or a related field.

• Minimum 7 years in software QA or software validation.

• Minimum 2+ years in a leadership or project management role delivering high-quality software on time and within scope.

• Experience in regulated environments, preferably within clinical research, healthcare technology, or life sciences.

• Proven track record driving quality improvements using metrics, RCA, and CAPA methodologies.

• Experience managing global teams and offshore resources is a plus.

• Strong understanding of SDLC, Agile delivery, and Computer System Validation principles.

• Experience with test management and requirements tools (e.g., JIRA, Jama, TestRail).

• Knowledge of automation frameworks and test automation best practices.

• Excellent written and verbal communication skills.

• Ability to foster collaboration, resolve conflicts, and build trust across functions.

• Strong analytical skills and a continuous improvement mindset.

At Clario, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work—and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.