Group Director of Quality Assurance and Compliance

Role Purpose:

The role will be responsible for building one quality governance system across all manufacturing sites, strengthening GMP compliance, improving audit readiness, and creating a strong quality culture across the organization.
The role should operate independently from Operations and Plant Management, with direct access to the CEO / Executive Management when required.

Key Responsibilities:

1. Group Quality Governance
   
   • Establish one unified Group Quality Management System.
   • Define group quality policies, standards and minimum requirements.
   • Ensure consistent implementation across all manufacturing sites.
   • Standardize quality governance across cosmetics, aerosols, nutrition and packaging operations where applicable.
2. GMP & Compliance
   
   • Lead GMP compliance across all manufacturing sites.
   • Ensure compliance with ISO 22716 and other applicable quality standards.
   • Conduct regular internal quality and GMP audits.
   • Identify systemic quality risks before they become customer or regulatory issues.
   • Maintain continuous audit readiness.
3. CAPA, Deviation & Change Control
   Build and govern group-level systems for:
   
   • Deviations
   • CAPA
   • Change Control
   • OOS / OOT
   • Root Cause Analysis
   • Quality Risk Management

   Ensure corrective actions address the root cause and are not closed only as documentation.

4. Documentation & Data Integrity
   Strengthen control of:
   
   • SOPs
   • Batch Manufacturing Records
   • Specifications
   • Logbooks
   • Approval systems
   • Document changes
   • Record integrity
   • Data integrity

   Ensure documentation reflects actual operations and is consistently controlled across sites.

5. Audit Management
   Own quality preparation and follow-up for:
   
   • Customer audits
   • Regulatory inspections
   • Certification audits
   • Supplier audits
   Responsibilities include:
   
   • Audit preparation
   • Site readiness
   • CAPA responses
   • Follow-up and closure
   • Prevention of repeated observations
6. Site Quality Oversight
   Provide functional leadership and oversight to site quality teams.
   Monitor areas including:
   
   • GMP compliance
   • Deviations
   • CAPA
   • Customer complaints
   • Microbiology
   • Environmental monitoring
   • Hygiene
   • Pest control
   • Calibration
   • Validation
   • Cross-contamination controls
   • Warehouse quality compliance
7. Quality Authority
   The role must have the authority to:
   
   • Reject non-compliant materials
   • Restrict or reject batch release
   • Request investigations
   • Require CAPA
   • Escalate serious GMP risks
   • Stop or recommend suspension of activities when product quality or consumer safety may be compromised

   Quality decisions should not be overridden by production pressure.

8. Supplier Quality
   
   • Build supplier qualification and supplier quality management systems.
   • Conduct or supervise supplier quality audits.
   • Define supplier quality standards.
   • Work closely with procurement while maintaining independent quality authority.
9. Customer Complaints & Quality Intelligence
   
   • Review and trend customer complaints.
   • Monitor product defects and recurring quality issues.
   • Lead recall investigations where required.
   • Identify repeat deviations and systemic quality trends.
   • Convert quality data into preventive actions.
10. Quality Culture & Training
    Build an annual quality and GMP training program covering:
    
    • Production
    • Warehouse
    • QC
    • QA
    • Maintenance
    • Supply Chain
    • Relevant support functions

    The objective is to build quality ownership across the company, not only inside the QA department.

11. Management Quality Dashboard
    Develop and report group-level quality KPIs including:
    
    • Critical Deviations
    • Major Deviations
    • CAPA Closure
    • Repeat Deviations
    • Customer Complaints
    • Right First Time
    • Batch Rejection
    • OOS
    • Audit Findings
    • Audit CAPA Closure
    • Supplier Quality Performance
    • Training Compliance
    • Recall / Serious Quality Events

Requirements:

• Degree in Pharmacy, Science, Chemistry, Microbiology or a related technical field.
• Typically 12–15+ years of quality experience.
• Minimum 5+ years in a senior QA / Quality leadership role.
• Strong experience in GMP / cGMP.
• Strong knowledge of ISO 22716.
• Experience in multi-site quality management is highly preferred.
• Strong experience in external, customer and regulatory audits.
• Strong knowledge of CAPA, Deviations, Change Control, OOS/OOT and Quality Risk Management.
• Strong root cause analysis capability.
• Experience in supplier qualification and supplier audits.
• Strong documentation and data integrity background.
• Experience in cosmetics is preferred.
• Pharmaceutical QA background is highly valued.
• Experience in nutrition / supplements is a strong advantage.
• Experience in managing and developing QA / QC teams.
• Strong leadership personality and ability to challenge operations when required.
• High level of integrity and independence.
• Strong communication and senior management reporting skills.