Product Owner

About the role

We are seeking a highly motivated Product Manager / Product Owner with deep knowledge of Quality Management Systems (QMS) to support the design and delivery of configurable enterprise quality applications. This role combines product strategy input, application design, and agile product ownership, enabling the delivery of scalable solutions that support regulated industries such as life sciences, medical devices, manufacturing, and automotive. The ideal candidate brings a strong understanding of quality processes and enterprise software and can translate complex regulatory and operational requirements into intuitive, configurable product functionality. You will work closely with product leadership, engineering, UX, validation, and customer-facing teams to deliver high-impact solutions that improve quality operations and ensure compliance.

Responsibilities

• Contribute to the product vision and roadmap for assigned QMS applications by providing domain expertise, customer insights, and detailed requirements.
• Serve as Product Owner for engineering teams, managing the backlog, defining user stories, and prioritizing work to deliver high-value outcomes.
• Design scalable product features end-to-end, including workflows, data models, and functional and non-functional requirements aligned to regulatory and industry standards.
• Drive continuous improvement through workflow automation, product innovation, and alignment with customer and business needs.
• Collaborate cross-functionally with Engineering, QA, UX, Product Leadership, and customer-facing teams to ensure high-quality delivery and adoption.
• Support Agile execution and release planning to deliver enhancements effectively and on schedule.
• Take accountability for the success, adoption, and ongoing evolution of assigned product areas, balancing customer needs, technical constraints, and business objectives.

Required Skills

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, Business, or related field.
• 4+ years of experience in product management, product ownership, business analysis, or related roles within enterprise software.
• 2+ years of experience working with web-based workflow or configurable systems.
• Experience working with Quality Management System (QMS) processes (e.g., CAPA, Audit, Document Control, Change Management).
• Strong understanding of the software development lifecycle, including requirements definition, engineering, QA, and deployment.
• Ability to translate business needs into clear, actionable product requirements.
• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management skills.
• Ability to manage multiple priorities in a fast-paced environment.

Preferred Qualifications

• Experience with enterprise QMS platforms such as ETQ Reliance, Veeva Vault QMS, MasterControl, TrackWise, or ComplianceQuest.
• Experience working in regulated industries such as life sciences, medical devices, pharmaceuticals, automotive, or aerospace.
• Familiarity with regulatory and validation frameworks (e.g., GAMP 5, CSA, FDA 21 CFR Part 11, Annex 11).
• Experience designing configurable enterprise applications or workflow-driven systems.

Nice to Have

• Experience applying automation, analytics, or AI to quality processes.
• Knowledge of data-driven quality insights or predictive quality systems.
• Experience applying Computer System Assurance (CSA) principles, including risk-based validation and testing strategies for configurable systems.
• Experience working with global enterprise customers.