Technical Product Owner (PLM, QMS & Regulatory)

Job Description

Job Description

Product Ownership & Roadmap Management

·       Own the product vision, roadmap, and backlog for PLM, QMS, and regulatory digital capabilities, aligned to business priorities and technology strategy.

·       Prioritize enhancements, defects, integrations, and technical debt based on business value, compliance risk, user impact, and delivery capacity.

·       Define clear product outcomes, success measures, and value realization of metrics for assigned platforms and capabilities.

·       Partner with business leaders to convert strategic needs into actionable product increments, releases, and continuous improvement plans.

Regulatory Business Analysis & Requirements Definition

·       Lead discovery sessions, stakeholder interviews, workshops, and process reviews to elicit business, functional, technical, data, reporting, and compliance requirements.

·       Document business requirements, user stories, acceptance criteria, process flows, data needs, decision points, and current-state/future-state operating models.

·       Translate complex regulatory business processes into clear solution requirements for configuration, workflow automation, reporting, integrations, and analytics.

·       Conduct gap assessments between business needs, platform capabilities, regulatory expectations, and current process performance.

·       Ensure requirements are complete, testable, traceable, and aligned to business objectives, validation expectations, and system lifecycle controls.

PLM, QMS & Regulatory Process Enablement

·       Support end-to-end digital processes across product lifecycle management, , change control, quality events, deviations, CAPA, audits, complaints, registrations, claims, and regulatory documentation.

·       Identify opportunities to simplify manual work, reduce duplicate data entry, improve governance, and strengthen compliance controls across processes.

Solution Delivery, Testing & Validation

·       Partner with technical teams, vendors, and platform owners to design, configure, test, validate, and deploy scalable solutions.

·       Lead or support SIT, UAT, regression testing, defect triage, release readiness, cutover planning, and post-go-live hypercare.

·       Support Computer System Validation activities, including user requirements, functional specifications, risk assessments, test scripts, traceability, approvals, and validation evidence.

·       Ensure changes follow SDLC, Agile, change control, quality, cybersecurity, data privacy, and compliance expectations.

Stakeholder Engagement, Adoption & Governance

·       Serve as the primary business-facing partner for PLM, QMS, and regulatory digital capabilities, balancing stakeholder needs with enterprise standards and platform strategy.

·       Facilitate prioritization, decision-making, issue resolution, and trade-off discussions with business leaders, IT delivery teams, vendors, and governance forums.

·       Monitor adoption, feedback, incidents, recurring pain points, and enhancement demand to inform backlog priorities and continuous improvement opportunities.

Experience

·       7+ years of experience in product ownership, business analysis, systems analysis, or technology delivery within regulated environments.

·       Experience supporting PLM, QMS, Regulatory Information Management, document management, workflow, or enterprise quality/regulatory platforms. Must have hands on experience with Veeva Vault RegulatoryOne, Product Lifecycle Management and Quality Management Systems.

·       Strong understanding of product development, specification management, change control, quality events, CAPA, audits, complaints, submissions, registrations, claims, or regulatory documentation processes.

·       Experience working with cross-functional teams across R&D, Quality, Regulatory, Operations, IT, and external vendors.

·       Experience supporting validated systems, inspections, audits, and regulated technology delivery preferred.

Technical Skills

·       Strong knowledge of Agile, hybrid delivery, SDLC, backlog management, user story writing, acceptance criteria, and release planning.

·       Hands-on experience documenting business requirements, process maps, workflows, data flows, test cases, validation artifacts, and traceability matrices.

·       Working knowledge of GxP, FDA 21 CFR Part 11, EU Annex 11, data integrity, audit trails, electronic records/signatures, and change control expectations.

·       Familiarity with PLM, QMS, RIM, document management, reporting, analytics, integration, and workflow automation tools.

·       Experience with tools such as Jira, Azure DevOps, ServiceNow, Power BI, Visio, Miro, SharePoint, or similar platforms.

Soft Skills

·       Strong executive communication, facilitation, and stakeholder management skills.

·       Ability to bridge business process, regulatory requirements, quality expectations, and technical solution design.

·       Strong analytical thinking, structured problem solving, and ability to simplify complex cross-functional processes.

·       Comfortable influencing without authority and driving alignment across business, IT, vendor, and governance teams.

·       Ability to manage competing priorities, make value-based trade-offs, and deliver in a fast-paced regulated environment.

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Founded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money. Synkriom leads the industry with experience authentication of candidates.

Company Description

Founded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money. Synkriom leads the industry with experience authentication of candidates.