Senior NPI Program Lead — Regulated Manufacturing

Mirus Consulting Group; Juncos (PR); Sur place; USD 90 000 - 140 000; Plein temps

Résumé du poste

mîrus Consulting Group, based in Humacao, Puerto Rico, seeks a Senior Project Manager to lead complex New Product Introduction programs in a regulated manufacturing environment. You will drive from concept through commercialization, ensuring quality and regulatory compliance while guiding multiple functional teams.

Candidates should have advanced degrees and extensive PM experience in pharma/biotech, with expertise in governance, risk management, and change control, and be able to present to

Qualifications

• Experience leading NPI and technology transfers in regulated manufacturing.
• Proven ability to manage large cross-functional projects with business impact.
• Experience supporting product launch readiness and manufacturing readiness.
• Working knowledge of Ariba Sourcing, SAP, TrackWise.

Responsabilités

• Lead NPI programs from concept through commercialization and lifecycle management.
• Develop and execute project strategies aligning with goals.
• Provide governance across Manufacturing, Engineering, Quality, Supply Chain, Procurement, Regulatory, and Operations.
• Drive alignment and facilitate decision-making among stakeholders and leadership teams.
• Ensure operational readiness and successful technology transfer, startup and product launch activities.
• Identify, assess, and proactively manage project risks, issues, dependencies, and mitigation plans.
• Lead planning, execution, monitoring, and closure of multiple complex projects and programs.
• Develop and manage project schedules, budgets, resource plans, and deliverables.
• Coordinate cross-functional teams and stakeholders in a matrix environment.
• Monitor project performance and communicate status, milestones, risks, and KPIs to leadership.
• Facilitate governance meetings, steering committees, and executive updates.
• Drive Change Control and ensure compliance with quality systems and regulatory requirements.
• Support procurement, sourcing, contracting, and vendor management activities.
• Prepare executive-level presentations, reports, and strategic recommendations.
• Champion continuous improvement and share PM best practices.

Connaissances

NPI leadership

Cross-functional collaboration

Executive communication

Governance

Matrix leadership

Formation

Doctorate + 2 years project management experience

Masters + 4 years project management experience

Bachelor’s + 6 years project management experience

Outils

SAP

TrackWise

Ariba Sourcing

Project portfolio management tools

Description du poste

mîrus Consulting Group, based in Humacao, Puerto Rico, seeks a Senior Project Manager to lead complex New Product Introduction programs in a regulated manufacturing environment. You will drive from concept through commercialization, ensuring quality and regulatory compliance while guiding multiple functional teams.

Candidates should have advanced degrees and extensive PM experience in pharma/biotech, with expertise in governance, risk management, and change control, and be able to present to