SAP Validation Project Manager

RxCloud; California City (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

A leading healthcare technology firm in California City is seeking an experienced SAP Validation Project Manager to oversee GxP validation activities. You will coordinate project plans, align diverse teams, and ensure compliance with FDA and EMEA guidelines. The ideal candidate has strong project management, communication skills, and knowledge of computer system validation. This role involves significant collaboration with stakeholders to guarantee project goals are achieved while managing risks effectively.

Qualifications

• 5+ years of experience in project management, especially in validation.
• Experience with GxP regulations, FDA, and EMEA guidelines.
• Strong analytical and reporting skills.
• Organize validation activities and deliverables within project timelines.

Responsibilities

• Coordinate GxP validation activities among teams.
• Prepare and maintain validation project plans.
• Track and report on validation activities.
• Manage changes to ensure project goals are met and communicated clearly to stakeholders.
• Produce timely reporting of validation status across multiple releases.
• Analyze program risks and update RAID log accordingly.

Skills

Project management

Excellent communication (oral and written)

Attention to detail

Ability to work independently

Adaptability

Positive attitude

Knowledge of GxP regulations

Knowledge of computer system validation

Stakeholders register

Program Communications Management Plan

Program Weekly/Monthly Status report

Job description

About the job SAP Validation Project Manager

Job Requirements:

• Coordinate the GxP validation activities amongst the validation and functional/ technical team members
• Prepare and maintain the project plan for validation function based on overall project plan
• Track and report the status of the Validation activities against the project plan
• Organize validation related activities and deliverables in accordance with the project timelines.
• Make sure individual validation activities are aligned with the strategic direction of the program
  Develop an evaluation method to assess the validation workstream strengths and identify areas for improvement
• Manage Global project teams with a diverse array of Vendors, talents, and responsibilities
  Engage stakeholders to align validation workstream priorities, coordinate interdependencies, and navigate risks
• Manage changes and intervene as needed to ensure project goals are achieved
• Meet with stakeholders to make communication easy and transparent regarding project issues and decisions on services
• Produce accurate and timely reporting of validation workstream status throughout the implementation (multiple releases)
• Analyze program risks and update RAID log accordingly

Skills:

• Project management
• Excellent communication (oral and written) and attention to detail
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
• Knowledge of GxP regulations, FDA and EMEA guidelines including 21 CFR Part 11
• knowledge of computer system validation and GAMP -5 standards
• Stakeholders register
• Program Communications Management Plan
• Program Weekly/Monthly Status report
• Meeting Notes I Action Items post every meeting
• Project Change Request / Change Order if any v111. Go-Live Sign Off/ Final Project Acceptance