Risk & Compliance Section Head – QA

Job Purpose:

The Risk & Compliance Senior Specialist – QA is responsible for ensuring that all quality and compliance risks within the pharmaceutical manufacturing process are identified, assessed, and mitigated in alignment with regulatory and corporate requirements. The role involves overseeing risk management programs, compliance monitoring, and ensuring adherence to Good Manufacturing Practices (GMP) and regulations set by the Egyptian Drug Authority (EDA), WHO, FDA, and other global authorities.

Key Responsibilities:

Risk Management & Compliance:

• Develop, implement, and maintain risk management processes in compliance with GMP, EDA, WHO, FDA, and EU regulations.
• Conduct risk assessments related to pharmaceutical production, quality control, and validation activities.
• Lead the implementation of corrective and preventive actions (CAPA) for identified risks and non-conformities.
• Monitor and ensure compliance with regulatory, corporate, and quality system requirements.
• Support internal and external audits, including regulatory inspections, and ensure timely closure of findings.

Quality Assurance & Validation:

• Ensure that Quality Risk Management (QRM) principles are effectively integrated into quality systems.
• Review and approve validation protocols for pharmaceutical manufacturing and packaging processes.
• Support the qualification and validation of new equipment, utilities, and processes.
• Oversee documentation control to ensure compliance with regulatory requirements.

Regulatory & Documentation Compliance:

• Ensure adherence to Egyptian Drug Authority (EDA) guidelines and international regulations.
• Collaborate with cross-functional teams to maintain compliance with pharmacovigilance, product safety, and regulatory reporting.
• Develop and update Standard Operating Procedures (SOPs) related to risk management and compliance.
• Train employees on compliance policies, regulatory updates, and quality risk management best practices.

Qualifications & Experience:

• Bachelor’s degree in Pharmacy (BPharm) – a must.
• 3+ years of experience in Quality Assurance, Risk Management, or Compliance within the pharmaceutical industry.
• Strong knowledge of GMP, FDA, WHO, EDA, and EU regulatory requirements.
• Experience in risk assessment, CAPA management, and regulatory audits.
• Knowledge of validation processes, change control, and documentation management.
• Excellent command of English & Arabic (written and spoken).
• Strong analytical, problem-solving, and decision-making skills.
• Ability to lead cross-functional teams and work in a fast-paced regulatory environment.

Preferred Qualifications:

• Experience in sterile dosage forms, solid dosage forms, or biotechnology.
• Certification in Quality Risk Management (QRM), GMP, or Compliance (preferred but not mandatory).

Benefits:

• Competitive salary and performance-based incentives.
• Medical and social insurance coverage.
• Professional development and training opportunities.
• Exposure to international pharmaceutical regulations and career growth potential