QMS SME: GMP Compliance & Validation Leader

Pinnaql, Inc.; Barceloneta (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a Quality Management System SME to lead an end-to-end QMS review for GMP compliance.

Responsibilities include mapping end-to-end quality system, deviation/CAPA, change control, document control, and archival practices, aligning with FDA, EU GMP, and ICH guidance. The role covers GMP records and system interfaces, data integrity and ALCOA+ across ERP/MES/LIMS/eQMS, materials traceability, batch release robustness, and a

Qualifications

• Bachelor's Degree in Engineering is required.
• Minimum 6 years of experience in pharmaceutical, medical device or biotechnology industries.
• Fully bilingual English/Spanish with excellent oral skills.
• Proficiency with MS Windows and Microsoft Office applications.
• Strong knowledge of cGxP and regulatory guidance applied to regulatory compliance.
• Proven experience delivering QMS, data integrity, and batch-release assessments in FDA- and EU-regulated environments.

Responsibilities

• Perform End-to-End QMS Review and map the quality system in relation to GMP record creation, review, approval, and archival.
• Assess interfaces among ERP/MES/LIMS/eQMS and data integrity with ALCOA+ compliance.
• Evaluate materials traceability from intake to finished goods and recovery of lot genealogy.
• Review batch records and disposition workflows to ensure robust release decisions.
• Produce a risk-ranked gap analysis with actionable recommendations and a roadmap.

Skills

QMS

Data integrity

GMP compliance

Regulatory guidance (cGxP)

Cross-functional collaboration

Education

Bachelor's Degree in Engineering

Tools

ERP/MES/LIMS/eQMS

MS Windows

Microsoft Office

Job description

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a Quality Management System SME to lead an end-to-end QMS review for GMP compliance.

Responsibilities include mapping end-to-end quality system, deviation/CAPA, change control, document control, and archival practices, aligning with FDA, EU GMP, and ICH guidance. The role covers GMP records and system interfaces, data integrity and ALCOA+ across ERP/MES/LIMS/eQMS, materials traceability, batch release robustness, and a