GxP Project Manager

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.

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