Oracle ERP-Program Manager/ Project Manager (Medical Devices)

Qualifications

• Expertise experience managing ERP (Oracle) projects in manufacturing, life sciences, or medical device industries
• Proven experience leading cross-functional ERP implementations or rollouts
• Strong understanding of ERP functional modules (Procurement, Inventory, Manufacturing, Supply Chain, or Finance)
• Hands-on experience with Computer System Validation (CSV) and compliance documentation in FDA-regulated environments
• Demonstrated ability to manage stakeholders across IT, Quality, and Operations
• Excellent project planning, budgeting, and risk management skills
• Strong communication, leadership, and vendor management capabilities
• Applicants must be authorized to work for ANY employer in the U.

S.

We are unable to sponsor or take over sponsorship or employment visas currently

Responsibilities

• We are seeking an experienced ERP Project Manager/Program Manager with a strong background in Oracle ERP implementations and medical device or regulated manufacturing environments
• The ideal candidate will lead cross-functional ERP projects, ensuring compliance with FDA, ISO 13485, and 21 CFR Part 820 standards, while driving successful business transformation across manufacturing, supply chain, and quality functions
• Lead full lifecycle ERP implementation or enhancement projects (Oracle), from planning to go-live and post-production support
• Manage project scope, timelines, resources, budgets, and risk mitigation plans
• Work closely with business process owners, quality, regulatory, and technical teams to align business and system requirements
• Oversee functional design, validation (CSV), UAT, and change management activities
• Ensure ERP configuration aligns with medical device compliance and traceability requirements (Lot/Serial control, DMR, DHR, etc.)
• Facilitate project documentation, testing traceability, and validation deliverables (IQ/OQ/PQ)
• Manage vendors and system integrators; ensure deliverables meet business and compliance expectations
• Provide regular project reporting to senior leadership and ensure timely issue escalation and resolution
• Support training, adoption, and continuous improvement initiatives post go-live

Full Description

WHO WE ARE

Nextphase.ai is a Data Management solution provider focused on Data Operations services for enterprise data in the cloud.

We are leading the innovation agenda with our clients by delivering a portfolio of services to help them improve data quality and manage data governance for their cloud data.

NextPhase.ai data management services are tailored to achieve our client’s business outcomes thus enabling our clients to focus on monetizing their data while we handle data operations. Nextphase.ai provides you with a dynamic and fun work environment and encourages you to use creative thinking to solve client challenges.

The Role:

We are seeking an experienced ERP Project Manager/Program Manager with a strong background in Oracle ERP implementations and medical device or regulated manufacturing environments.

The ideal candidate will lead cross-functional ERP projects, ensuring compliance with FDA, ISO 13485, and 21 CFR Part 820 standards, while driving successful business transformation across manufacturing, supply chain, and quality functions.

Key Responsibilities

• Lead full lifecycle ERP implementation or enhancement projects (Oracle), from planning to go-live and post-production support.

• Manage project scope, timelines, resources, budgets, and risk mitigation plans.

• Work closely with business process owners, quality, regulatory, and technical teams to align business and system requirements.

• Oversee functional design, validation (CSV), UAT, and change management activities.

• Ensure ERP configuration aligns with medical device compliance and traceability requirements (Lot/Serial control, DMR, DHR, etc.).

• Facilitate project documentation, testing traceability, and validation deliverables (IQ/OQ/PQ).

• Manage vendors and system integrators; ensure deliverables meet business and compliance expectations.

• Provide regular project reporting to senior leadership and ensure timely issue escalation and resolution.

• Support training, adoption, and continuous improvement initiatives post go-live.

Required Qualifications

• Expertise experience managing ERP (Oracle) projects in manufacturing, life sciences, or medical device industries.

• Proven experience leading cross-functional ERP implementations or rollouts.

• Strong understanding of ERP functional modules (Procurement, Inventory, Manufacturing, Supply Chain, or Finance).

• Hands-on experience with Computer System Validation (CSV) and compliance documentation in FDA-regulated environments.

• Demonstrated ability to manage stakeholders across IT, Quality, and Operations.

• Excellent project planning, budgeting, and risk management skills.

• Strong communication, leadership, and vendor management capabilities.

• PMP, PRINCE2, or Agile certification preferred.

Preferred Qualifications

• Direct experience in Medical Device industry or Pharma with FDA/ISO compliance exposure.

• Familiarity with GxP, ISO 13485, and 21 CFR Part 820 quality regulations.

• Exposure to MES, PLM, or LIMS integrations with ERP systems.

• Experience managing global ERP rollouts or multi-site implementations.

Applicants must be authorized to work for ANY employer in the U.

S.

We are unable to sponsor or take over sponsorship or employment visas currently.

NextPhase.ai is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.