QMS Expert — GMP Compliance & Quality Systems

Pinnaql, Inc.; Humacao (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Quality Management System (QMS) SME to lead end-to-end QMS reviews and enhancements in FDA/EU-regulated environments. You will map governance, document control, deviation management, and data integrity across multiple systems.

The role requires 6+ years in pharma/biotech, engineering degree, and fluency in English and Spanish. On-site work in Manatí, Puerto Rico is expected; extended hours may be required. Equal opportunity employer.

Qualifications

• Bachelor's Degree in Engineering required.
• Minimum 6 years in pharmaceutical, medical device, or biotechnology industries.
• Experience in direct process/manufacturing areas.
• Fully bilingual English/Spanish with excellent oral skills.
• Proficiency with MS Windows and Microsoft Office applications.
• Strong knowledge of cGxP and regulatory guidance.
• Proven experience delivering QMS, data integrity, and batch-release assessments in FDA- and EU-regulated environments.
• Demonstrated GMP records management, interfaces (ERP/MES/LIMS/eQMS), and materials traceability knowledge.

Responsibilities

• Perform End-to-End QMS review and gap analysis.
• Map end-to-end quality system related to GMP records and archival.
• Review deviation/CAPA, change control, document control, complaints, and product quality review.
• Assess interfaces and data integrity across ERP/MRP, MES, LIMS, QMS/eQMS systems.
• Evaluate batch release workflow and data supporting disposition.
• Benchmark processes against QMS standards and regulatory guidance.
• Deliver a prioritized recommendations and an implementation roadmap.

Skills

QMS exposure

Regulatory compliance

GMP records management

ERP/MES/LIMS/eQMS interfaces

Bilingual English/Spanish

MS Office proficiency

Process/manufacturing experience

Education

Bachelor's Degree in Engineering

Tools

MS Office

Job description

Validation & Engineering Group, Inc. seeks a Quality Management System (QMS) SME to lead end-to-end QMS reviews and enhancements in FDA/EU-regulated environments. You will map governance, document control, deviation management, and data integrity across multiple systems.

The role requires 6+ years in pharma/biotech, engineering degree, and fluency in English and Spanish. On-site work in Manatí, Puerto Rico is expected; extended hours may be required. Equal opportunity employer.