Project Manager - PMO

Job Description

Job Description

Position Summary

The Project Manager facilitates all non-client site projects, ensuring they are completed on time, within budget, and meet quality standards while coordinating with cross-functional teams.

Duties and Responsibilities

• Oversee the planning, implementation, and tracking of projects from initiation to completion, ensuring they align with company goals and customer expectations
• Manage capital projects including cost, schedule and budget for projects. This encompasses monthly forecasting and planning project priorities to stay within the allocated funding for the year.
• Manage project resources, schedules, and budgets, ensuring that projects are delivered on time and within scope
• Identify potential project risks, assess their impact, and develop mitigation strategies to minimize disruptions
• Develop and maintain comprehensive project documentation, including change controls, User Requirement Specifications, project plans, progress reports, and final evaluations, to ensure transparency and effective communication among stakeholders
• Negotiate with suppliers and contractors for resources and materials, ensuring quality standards are met and costs are controlled
• Implement lean manufacturing principles to optimize processes for efficiency improvements and cost reduction
• Manage the Project Management Office (PMO) list of projects including resource planning, project priorities and project hopper/funnel for next up projects.
• Communicate PMO dashboard metrics on a monthly basis with senior leadership.
• Other duties as assigned

Regulatory Responsibilities

• Maintain working knowledge of 21 CFR 210/211, 21 CFR 820, EU Annex 1, and related regulations
• Ensure all work is performed in accordance with current regulatory requirements and internal SOPs
• Support data integrity initiatives and provide input to compliance metrics

Supervisory Responsibilities

• Collaborate with various departments, including engineering, production, quality assurance, and supply chain, to ensure project requirements are met and to resolve any technical challenges
• Coordinate staffing to support manufacturing schedules and priority projects

Experience

• Three (3) to five (5) years of experience in project management within the capital project and continuous improvement projects sector
• Strong understanding of pharmaceutical manufacturing processes and project management methodologies

Education

• Bachelor’s degree in Engineering, Business Administration, or a related field is typically required
• Master’s degree or certification in Project Management is preferred

Knowledge, Skills & Abilities

• Excellent communication, interpersonal and leadership skills
• Strong problem-solving and analytical abilities
• Organizational skills
• Familiarity with project management tools and techniques, such as Gantt charts and risk management
• Solid understanding of cGMP and regulatory requirements (FDA, EU, etc.)
• Comfortable working in a dynamic, fast-paced environment.
• Experience with QMS tools such as MasterControl is preferred
• Proficiency in Microsoft Office Suite

Physical Requirements

• Ability to sit for prolonged periods of time
• Ability to lift up to 10lbs
• Ability to stand for prolonged periods of time