GxP Project Manager

NexInfo Solutions, Inc.; Foster City (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

NexInfo Solutions, Inc. is seeking an experienced Project Manager with pharma GxP expertise to oversee end-to-end project planning and execution.

You will manage budgets, timelines, and cross-functional teams across multiple initiatives, coordinating with suppliers and customers to ensure successful releases. Ideal candidates have 10+ years in project management and 3+ years in Pharma, with strong communication skills and proficiency in MS Project, Excel, Visio, PowerPoint, and SharePoint.

Qualifications

• 10+ years project management experience.
• 3+ years Pharma experience.
• Experience in Pharma and GxP compliance / 21 CFR Part 11.
• Experience in leading projects on-time, on-schedule, within budget.

Responsibilities

• Manage a portfolio of complex initiatives that span one or multiple lines of business.
• Provide on-site leadership for project team by building and motivating team members to meet project goals.
• Full project life cycle ownership: successful project delivery from initiation to deployment for one or more initiatives.
• Lead projects from requirements definition through deployment, identifying schedules, scopes, budget estimations, and project implementation plans, including risk mitigation.
• Develop clear communication plans with roles and responsibilities to ensure all project team members are clear on their role, aware of project progress and all stakeholders are informed.
• Coordinate internal and external resources, ensuring projects remain within scope, schedule, and defined budgets.
• Report on project success criteria results, metrics, testing, and deployment management activities.
• Work creatively and analytically in a problem-solving environment demonstrating teamwork, innovation, and excellence.
• Participate in establishing practices, templates, policies, tools, and partnerships that facilitate project success.
• Prepare estimates and detailed project plan for all phases of the project.
• Manage the day-to-day project activities and resources.
• Monitor staff performance and complete performance reviews.
• Provide status reporting regarding project milestones, deliverable, dependencies, risks, and issues.
• Understand interdependencies between technology, operations, and business needs.
• Manage ongoing quality control and participate in quality issue resolution.
• Report project outcomes and/or risks to the appropriate management channels as needed escalating issues as necessary based on project work plans.
• Delegate tasks and responsibilities to appropriate personnel.
• Establish and maintain relationships with appropriate client stakeholders, providing day-to-day contact on project status and changes.
• Develop the project team to ensure maximum performance, providing purpose, direction, and motivation.
• Develop and maintain partnerships with outside resources including third-party vendors and researchers.

Skills

Project management

Pharma experience

GxP compliance

Budgeting

Cross-functional leadership

Vendor management

Stakeholder communication

Risk management

Executive influence

Tools

MS Project

Excel

Visio

PowerPoint

SharePoint

Job description

Role Summary

The driving force behind constant business growth is the presence of skilled and dedicated project managers. The ideal candidate will have pharma experience with GxP Technical Development or Pharma Biotech experience with strong work plan development and progress oversight skills. He/She will be expected to oversee the planning and implementation of an entire project through budgeting, assessing team members, engage with suppliers and plan the project release. Their duties include setting deadlines, providing feedback and communicating with customers and cross-functional partners about the project status.

The driving force behind constant business growth is the presence of skilled and dedicated project managers. The ideal candidate will have pharma experience with GxP Technical Development or Pharma Biotech experience with strong work plan development and progress oversight skills. He/She will be expected to oversee the planning and implementation of an entire project through budgeting, assessing team members, engage with suppliers and plan the project release. Their duties include setting deadlines, providing feedback and communicating with customers and cross-functional partners about the project status.

Job Description

• Manage a portfolio of complex initiatives that span one or multiple lines of business
• Provide on-site leadership for project team by building and motivating team members to meet project goals
• Full project life cycle ownership: successful project delivery will include full implementation from initiation to deployment for one or more initiatives simultaneously
• Lead projects from requirements definition through deployment, identifying schedules, scopes, budget estimations, and project implementation plans, including risk mitigation
• Develop clear communication plans with roles and responsibilities to ensure all project team members are clear on their role, aware of project progress and all stakeholders are informed based on agreed upon communication plan
• To coordinate internal and external resources, ensuring projects remain within scope, schedule, and defined budgets, in collaboration with project staff from various functional departments
• Report on project success criteria results, metrics, testing, and deployment management activities
• Work creatively and analytically in a problem-solving environment demonstrating teamwork, innovation, and excellence
• Participate in establishing practices, templates, policies, tools, and partnerships that facilitate project success
• Prepare estimates and detailed project plan for all phases of the project
• Manage the day-to-day project activities and resources
• Monitor staff performance and complete performance reviews
• Provide status reporting regarding project milestones, deliverable, dependencies, risks, and issues
• Understand interdependencies between technology, operations, and business needs
• Manage ongoing quality control and participate in quality issue resolution
• Report project outcomes and/or risks to the appropriate management channels as needed escalating issues as necessary based on project work plans
• Delegate tasks and responsibilities to appropriate personnel
• Establish and maintain relationships with appropriate client stakeholders, providing day-to-day contact on project status and changes
• Develop the project team to ensure maximum performance, providing purpose, direction, and motivation
• Develop and maintain partnerships with outside resources including third-party vendors and researchers

Skills And Qualifications

• 10+ years project management experience
• 3+ years Pharma experience
• Experience in Pharma and GxP compliance / 21 CFR Part 11
• Experience in successfully leading projects and programs on-time, on-schedule. and within budget parameters
• Proven success working with all levels of management
• Strong written, verbal, and presentation communication skills
• Advanced level of proficiency with MS Project, Excel, Visio, PowerPoint, and SharePoint, with experience presenting to stakeholders and / or Senior Leadership
• Interpersonal skills to influence and spur change, facilitate, and enhance performance within a cross-functional environment
• Demonstrate decisiveness in resolving business problems, making decisions, and identifying priorities
• Experience drafting and submitting budget proposals and recommending subsequent budget changes where necessary
• Experience leading, motivating, and managing various project and program team sizes, including internal and external resources, while holding team accountable for performance
• Experience influencing and gaining buy-in from executives, sponsors, team members, stakeholders, and peers

Note: IT/Infra PM's will not be considered