Site Quality Head (Pharma | Life Sciences)

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

The Site Quality Head provides strategic and operational leadership across Quality Assurance, Quality Control, and Quality Systems within a regulated manufacturing environment. This role is accountable for ensuring full compliance with current Good Manufacturing Practices (cGMP), regulatory standards, and client requirements, while driving a culture of quality, continuous improvement, and inspection readiness.

The position serves as the key authority on all quality-related matters, including batch disposition, regulatory inspections, and quality systems governance, and acts as the primary liaison with regulatory bodies.

Key Responsibilities:

Quality Leadership & Governance

• Lead and oversee end-to-end QA and QC operations, including raw materials, in-process controls, finished product release, microbiological testing, and stability programs.
• Serve as the final authority for batch disposition, including approval or rejection of raw materials, packaging materials, and finished products.
• Establish and maintain a robust Pharmaceutical Quality System (PQS) aligned with global regulatory expectations.

Regulatory Compliance & Inspection Readiness

• Ensure compliance with cGMP, PIC/S, FDA, and other applicable regulatory standards.
• Lead regulatory inspections, client audits, and internal audits; ensure timely closure of audit observations.
• Act as the primary point of contact for regulatory authorities and external auditors.

Quality Systems Management

• Oversee core quality systems including deviations, CAPA, change control, complaints, risk management, and validation.
• Review and approve critical GMP documentation such as validation protocols/reports, SOPs, risk assessments, and investigation reports.
• Ensure effective implementation of data integrity and documentation practices across all quality systems.

Operational Excellence & Continuous Improvement

• Drive continuous improvement initiatives across manufacturing and quality processes to enhance compliance, efficiency, and product quality.
• Provide strategic direction on validation, qualification, and process improvements.
• Ensure effective product lifecycle management including stability and ongoing process verification.

Stakeholder Management

• Collaborate cross-functionally with Production, Engineering, Supply Chain, and Technical Services to ensure alignment on quality standards.
• Manage client communications related to quality concerns, product complaints, and recalls, ensuring timely and compliant resolution.

People Leadership

• Lead, develop, and mentor QA/QC leaders and teams, including Quality Systems, Validation, and Compliance functions.
• Establish training frameworks to ensure organization-wide adherence to cGMP and quality standards.
• Build a high-performance culture focused on accountability, compliance, and continuous learning.

Scope of Responsibility

• Direct oversight of QA, QC, Validation, Quality Systems, and Compliance Heads
• Indirect oversight of laboratory analysts, specialists, and technical personnel

Qualifications:

Education

• Bachelor's Degree in Pharmacy, Chemistry, Chemical Engineering, or related field
• Licensed Pharmacist or Chemist preferred

Experience

• Minimum 10+ years of progressive experience in Quality within pharmaceutical, biotech, or regulated manufacturing
• At least 5 years in a senior leadership or site quality role
• Strong exposure to regulatory inspections (e.g., FDA, PIC/S, EU GMP)

Technical Expertise

• Deep knowledge of cGMP, Pharmaceutical Quality Systems (PQS), and regulatory frameworks
• Strong experience in:
• Batch release and disposition
• Validation and qualification (process, cleaning, equipment)
• Deviation investigation, CAPA, and change control
• Product complaints and recall management
• Supplier qualification and audits
• Data integrity and risk management

Leadership & Competencies

• Strong leadership presence with proven ability to manage cross-functional teams
• High level of accountability and decision-making authority in regulated environments
• Excellent stakeholder management and regulatory communication skills
• Strategic mindset with strong execution capability