- Remote, United States
- Remote
- Full-time · Senior
- $83K–$95K per year
- 8+ years
Leading the implementation of Ketryx and associated quality and engineering platforms in a regulated environment, managing cross-functional workstreams and stakeholder stakeholders.
Compensation
The annual salary for this position ranges from $83,000 to $94,500, depending on experience and qualifications.
Responsibilities
- Lead the end-to-end implementation of Ketryx, including planning, requirements gathering, configuration, integration, validation, rollout, and transition to support.
- Manage multiple workstreams across implementation, integration, validation, quality, vendor, and business teams to ensure alignment and timely delivery.
- Drive program governance, milestone tracking, RAID management (risks, assumptions, issues, and dependencies), and executive-level reporting.
- Coordinate integrations with platforms such as Jira, IBM ELM/DOORS DNG, ALM, and other enterprise engineering and quality systems.
- Ensure testing, validation, traceability, documentation, and release activities align with Software Lifecycle, Quality Management System, and regulatory requirements.
Requirements
- Nice to have: Medical Device
- Nice to have: Life Sciences
- Nice to have: Digital Health
- Nice to have: Pharmaceutical
- Nice to have: 21 CFR Part 11