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