External Supply Quality Lead: Change Control & Compliance

Mirus Consulting Group; Juncos (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

mîrus Consulting Group in Humacao, Puerto Rico, seeks a Specialist Manufacturing to serve as External Supply Quality Record Owner, leading supplier-related Change Control records to ensure compliance, quality, and timely execution.

You will drive cross-functional collaboration with Quality, Manufacturing, Regulatory, and suppliers, manage Change Control activities using TrackWise and SAP, and maintain GMP compliance throughout the records lifecycle.

Qualifications

• Doctorate Degree with relevant manufacturing operations exposure is preferred.
• Master’s Degree plus 2 years of Manufacturing Operations experience.
• Bachelor’s Degree plus 4 years of Manufacturing Operations experience.

Responsibilities

• Serve as External Supply Quality Record Owner, responsible for managing and executing supplier-related Change Control quality records with minimal supervision.
• Manage and execute Change Control activities associated with external suppliers, ensuring documentation, impact assessments, approvals, and timely closures.
• Lead cross-functional meetings with Quality, Manufacturing, Supply Chain, Regulatory, Engineering, and External Supply stakeholders to drive progress and resolve issues.
• Assess supplier-related quality records using risk-based decision-making to ensure compliance and product quality.
• Monitor Change Control timelines, identify risks, escalate issues, and drive actions to meet deadlines.
• Coordinate the implementation of supplier changes and ensure alignment with internal procedures and regulatory requirements.
• Utilize TrackWise and SAP systems to manage quality records, documentation, workflows, and related activities.
• Ensure accurate and compliant documentation of Change Controls, actions, approvals, and supporting records.
• Collaborate with internal and external stakeholders to facilitate effective communication and execution of quality-related initiatives.
• Support audits, inspections, and quality reviews by providing documentation and Change Control records as required.
• Analyze trends, identify process improvement opportunities, and recommend solutions to enhance quality system effectiveness.
• Maintain compliance with GMP, company policies, and applicable regulatory requirements.

Skills

Change Control processes

Quality systems

Supplier quality management

Cross-functional collaboration

Education

Doctorate Degree

Master’s Degree and 2 years of Manufacturing Operations experience

Bachelor’s Degree and 4 years of Manufacturing Operations experience

Tools

TrackWise

SAP

Job description

mîrus Consulting Group in Humacao, Puerto Rico, seeks a Specialist Manufacturing to serve as External Supply Quality Record Owner, leading supplier-related Change Control records to ensure compliance, quality, and timely execution.

You will drive cross-functional collaboration with Quality, Manufacturing, Regulatory, and suppliers, manage Change Control activities using TrackWise and SAP, and maintain GMP compliance throughout the records lifecycle.