Pharma Site Quality Head: Regulatory & QA Leader

HRTx Inc.; Calamba; On-site; PHP 2,500,000 - 4,500,000; Full time

Job summary

HRTx Inc. seeks a Site Quality Head to lead QA, QC, and Quality Systems in a regulated manufacturing setting in the Philippines. This role drives cGMP compliance, continuous improvement, and inspection readiness while ensuring batch disposition and regulatory readiness.

The candidate will oversee QA/QC operations, manage regulatory inspections, and champion data integrity, risk management, and supplier qualification across the site through strategic leadership and cross-functional collaboration.

Qualifications

• Bachelor's degree in a related field and licensed pharmacist preferred.
• 10+ years in quality within pharma/regulated manufacturing.
• Strong exposure to regulatory inspections (FDA, PIC/S, EU GMP).

Responsibilities

• Lead end-to-end QA and QC operations, including batch release and disposition.
• Oversee Quality Systems governance, deviations, CAPA, change control, and documentation.
• Ensure cGMP compliance, inspection readiness, and regulatory liaison.
• Manage regulatory inspections, audits, and timely closure of observations.
• Develop training frameworks and mentor QA/QC teams.

Skills

QA Leadership

Regulatory Inspection

Quality Systems

Cross-Functional Leadership

Data Integrity

Education

Bachelor's Degree in Pharmacy

Licensed Pharmacist

Tools

CAPA System

Change Control System

Document Control

Job description

HRTx Inc. seeks a Site Quality Head to lead QA, QC, and Quality Systems in a regulated manufacturing setting in the Philippines. This role drives cGMP compliance, continuous improvement, and inspection readiness while ensuring batch disposition and regulatory readiness.

The candidate will oversee QA/QC operations, manage regulatory inspections, and champion data integrity, risk management, and supplier qualification across the site through strategic leadership and cross-functional collaboration.