The Role
Lead end-to-end MES program for a pharmaceutical/medical device manufacturing site: govern planning, delivery, integration (BPCS, SAP, Cornerstone, equipment), ensure compliance, minimize production disruption, manage budgets/schedules/resources/risks, drive go‑live, hypercare, training, change management, and continuous improvement.
Summary Generated by Built In
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
Responsibilities:
- Program Manager for the Manufacturing Execution System (MES) at the manufacturing site provides end‑to‑end leadership for the planning, governance, and execution of MES initiatives supporting manufacturing operations.
- Leads cross‑functional teams in deploying and sustaining the standardized global MES template (Critical Manufacturing), including required Ponce‑specific localizations, while ensuring alignment to business priorities, operational readiness, and enterprise standards.
- Accountable for integrated delivery across scope, schedule, budget, resources, risks, quality and compliance, site readiness, training and change management, go‑live, and hypercare.
- The role ensures minimal disruption to production and a controlled transition from implementation to steady‑state operations.
- Program scope includes enabling real‑time production visibility, replacing paper‑based records with electronic DHR (eDHR), and coordinating integration between MES and site and enterprise systems such as BPCS ERP, Cornerstone/CSOD, equipment connectivity, and other applications defined in project charters and SOWs.
- Provide overall program leadership and governance for MES initiatives, defining objectives, success metrics, operating cadence, and escalation paths.
- Plan, execute, and monitor MES projects from initiation through delivery, owning integrated schedules, dependencies, risks, and outcomes across cross‑functional and departmental teams.
- Manage financial and resource aspects of the program, including budgets, forecasts, SOW execution, vendor performance, and efficient allocation of internal resources.
- Assess complex, ambiguous project issues and develop effective resolutions to meet productivity, quality, compliance, and customer satisfaction objectives.
- Lead risk, issue, and change management activities, ensuring adoption readiness and adherence to PMO, quality, and enterprise standards.
- Provide clear, concise project status reporting and executive‑level insights on progress, risks, and financials.
- Drive continuous improvement by strengthening delivery processes, tools, and consistency of execution, capturing lessons learned to improve future initiatives.
- Bachelor's degree in engineering or related area (additional PMP, Agile, etc certifications preferred
- 10+ years of related experience preferred
- 5+ years in Project Management
- Manufacturing Execution System experience (Critical Manufacturing preferred)
- Medical device quality, manufacturing, and regulatory experience
- BPCS Experience
- SAP Experience
- Practical experience leading and managing the execution of projects and operational initiatives within a technical or professional discipline.
- Advanced knowledge and skills in project or program management with an understanding of downstream impacts across the organization.
- While preference is given to candidates based in Ponce with the ability to work on‑site, qualified candidates located elsewhere in Puerto Rico will be considered, provided they are able to travel to the Ponce site at least bi‑weekly.
- Shift: 1st
Skills Required
- Bachelor's degree in engineering or related area
- PMP, Agile or similar certifications
- 10+ years of related experience
- 5+ years in Project Management
- Manufacturing Execution System (MES) experience
- Critical Manufacturing MES experience
- Medical device quality, manufacturing, and regulatory experience
- BPCS ERP experience
- SAP experience
- Experience leading and managing execution of technical projects and operational initiatives
- Advanced project/program management knowledge and downstream impact understanding
- Ability to work on-site in Ponce or travel to Ponce at least bi-weekly
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
