Project Manager – New Product & Strategic Programs
📍 Dorado, Puerto Rico | 🕒 Onsite | 📅 Contract Role- 12 months project
About the Role
We are seeking a dynamic Project Manager to lead high-impact, cross-functional initiatives within a regulated manufacturing environment. This role is responsible for driving strategic projects and new product introductions, ensuring alignment with operational goals, timelines, and compliance standards.
You will play a critical role in bringing new products to market while coordinating efforts across multiple teams and ensuring successful execution from concept through completion.
Key Responsibilities
Project Leadership & Execution
• Lead all phases of project management, including initiation, planning, execution, monitoring, and closeout
• Define project scope, timelines, budgets, and resource requirements
• Establish milestones and ensure adherence to schedules and deliverables
Cross-Functional Collaboration
• Drive alignment across Operations, Quality, Regulatory, R&D, and Supply Chain teams
• Act as the primary liaison between project teams and leadership
• Facilitate effective communication and decision-making across stakeholders
New Product Introduction (NPI/NPD)
• Support new product launches from development through commercialization
• Ensure deliverables meet operational and contract expectations
• Apply New Product Excellence (NPE) methodologies and best practices
Risk & Performance Management
• Identify and manage project risks using tools such as FMEA and hazard analysis
• Lead root cause investigations and support CAPA implementation
• Monitor project performance related to cost, schedule, and technical execution
Process & Compliance Oversight
• Ensure adherence to GMP, FDA regulations, and internal quality systems
• Maintain proper documentation, including project plans, meeting minutes, and issue logs
• Support Value Improvement Projects (VIP) and continuous improvement initiatives
Qualifications & Experience
• 5–7+ years of experience in Manufacturing Engineering, Quality Engineering, or Project Management within a regulated industry
• PMP Certification Preferred.
• Strong knowledge of FDA regulations (21 CFR Part 820), GMP, and ISO 13485
• Experience with new product introductions (NPI/NPD), process validation, and equipment qualification
• Hands-on experience with risk management, root cause analysis, and CAPA systems
• Proven ability to lead cross-functional teams and complex projects
• Strong communication, leadership, and stakeholder management skills
What We’re Looking For
• Strategic thinker with strong execution skills
• Ability to manage multiple priorities in a fast-paced environment
• Strong leadership presence with the ability to influence without authority
• Commitment to quality, compliance, and continuous improvement
Why This Opportunity?
This role offers the opportunity to lead impactful projects, work with cross-functional teams, and contribute to the successful launch of products in a highly regulated environment.