QMS Excellence Lead – GMP & Regulatory Compliance

Pinnaql, Inc.; Carolina (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 across GMP records and interfaces.

You will map and optimize deviation/CAPA, change control, document control, complaint handling, and batch review processes to ensure data integrity and regulatory alignment. Responsibilities include inventorying GMP records and systems, evaluating data handoffs, and identifying gaps with recommended corrective actions and a strategic implementation

Qualifications

• Bachelor's degree in engineering and minimum 6 years in pharma/biotech/medical device.
• Experience delivering QMS, data integrity, and batch-release assessments in FDA/EU-regulated environments.
• Fully bilingual English/Spanish with excellent oral skills.

Responsibilities

• Map end-to-end quality system related to GMP record creation, review, approval, and archival.
• Review core QMS elements and their interactions (deviation, CAPA, change control, document control, complaint handling, QPR).
• Assess alignment with BMS QMS Standard and applicable regulations (FDA, EU GMP, ICH Q7/Q9/Q10).
• Inventory GMP records and systems (ERP/MRP, MES, LIMS, QMS/eQMS, WMS, equipment).
• Map interfaces and data handoffs; evaluate data integrity and ALCOA+ across records.
• Identify single points of failure and gaps impacting release packages.

Skills

QMS

GMP

Regulatory Compliance

Data Integrity

AlCOA+

Documentation Control

Deviation & CAPA

Change Control

Regulatory Guidance

Education

Bachelor's Degree in Engineering

Tools

MS Windows

Microsoft Office

Job description

Validation & Engineering Group, Inc. seeks a Quality Management System (QMS) SME to lead end-to-end QMS reviews across GMP records and interfaces.

You will map and optimize deviation/CAPA, change control, document control, complaint handling, and batch review processes to ensure data integrity and regulatory alignment. Responsibilities include inventorying GMP records and systems, evaluating data handoffs, and identifying gaps with recommended corrective actions and a strategic implementation