Project Manager (Regulated Industry)
Title: Project Manager (Regulated Industry)
Location: Puerto Rico (Open to Puerto Rico Residents)
Function: Cross-Functional / Enterprise Programs
Engagement Type: Contract opportunity through ProQuality Network
Positions: 1
100% onsite work
Position Overview
ProQuality Network is seeking a Project Manager to support our client in Dorado. This contract role provides strategic leadership to high-impact, site-level initiatives, ensuring successful execution of new product launches and Value Improvement Projects (VIP).
The Project Manager will lead cross-functional teams across Operations, Quality, Engineering, Regulatory, R&D, and Supply Chain to drive project performance aligned with cost, schedule, and technical objectives. This role requires strong leadership, structured project governance, and the ability to influence across multiple stakeholders in a regulated environment.
Key Responsibilities
Project Planning & Definition
- Define project scope, objectives, deliverables, timelines, cost estimates, and risk mitigation strategies.
- Facilitate cross-functional workshops to develop and align project proposals.
- Establish clear milestones and measurable performance indicators.
Project & Program Execution
- Lead all project phases from initiation through close-out, ensuring operational readiness.
- Monitor adherence to schedules, budgets, and technical requirements.
- Identify project risks and implement timely corrective actions.
- Drive accountability and ownership across cross-functional teams.
New Product Excellence (NPE) & NPI Support
- Direct Operations-focused execution of New Product Introduction (NPI/NPD) initiatives.
- Ensure equipment qualification, process validation, and manufacturing readiness activities are completed on time.
- Implement NPE methodologies and manage associated risks and deliverables.
Value Improvement Projects (VIP)
- Oversee VIP initiatives aligned with contractual and operational goals.
- Identify and manage risks impacting cost, efficiency, or product quality.
- Drive sustainable performance improvements across site operations.
People & Cross-Functional Leadership
- Lead large, multi-disciplinary, and potentially multi-site project teams.
- Foster collaboration, alignment, and performance accountability.
- Provide input on team member performance when applicable.
Process & Documentation Management
- Ensure projects follow established quality system procedures and governance standards.
- Maintain documentation discipline including meeting minutes, risk logs, issue trackers, and performance metrics.
- Reinforce compliance with engineering change processes and controlled documentation systems.
Communication & Governance
- Serve as liaison between project teams and site leadership.
- Lead structured phase reviews with emphasis on cost, schedule, and technical performance.
- Communicate complex information clearly to diverse stakeholders.
Required Qualifications
- 5–7+ years of experience in Manufacturing Engineering or Quality Engineering within an FDA-regulated industry (medical devices, pharmaceuticals, biotechnology, diagnostics, or related fields).
- Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices (GMP), and ISO 13485.
- Proven experience supporting New Product Introduction (NPI/NPD), including process development, equipment qualification, and process validation.
- Hands-on experience with risk management tools (FMEA, hazard analysis), root cause investigations, and CAPA systems.
- Demonstrated collaboration with Operations, QA, Regulatory Affairs, R&D, and Supply Chain teams.
- Familiarity with engineering change control processes, controlled documentation systems, and manufacturing readiness requirements.
- Experience ensuring compliance with quality system procedures throughout the full project lifecycle.
Quality & Compliance Expectations
- Demonstrate strong commitment to patient safety, product quality, and regulatory compliance.
- Adhere to all applicable quality policies, procedures, and site requirements.
- Support a work environment aligned with Environmental Health & Safety (EHS) and Energy policies.
- For roles with supervisory responsibilities: ensure adequate resources and promote a culture of quality and compliance.
Job Scope
- Applies in-depth technical and functional knowledge to drive project success.
- Integrates business priorities and cross-functional collaboration to achieve objectives.
- Provides leadership, coaching, and guidance to project teams.
- Solves problems of varying complexity using structured methodologies and sound judgment.
- Influences operational effectiveness and strategic project outcomes.
If you are a driven Project Manager with experience in regulated manufacturing environments and a passion for leading cross-functional initiatives, we invite you to apply through the job description link and submit your updated resume for consideration.