Summary position:

The Quality Director is ultimately responsible for ensuring the required quality of all products manufactured and released by the company. This role safeguards compliance with all applicable current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs), and relevant industry regulations and standards (e.g., FDA, ISO, EURO).

The Quality Director leads all external quality audits, oversees the implementation and maintenance of the Quality Management System (QMS), and drives a culture of continuous improvement and regulatory excellence. As a member of the Management Team, the Quality Director plays a key strategic role in shaping the direction of the company and ensuring that quality is at the core of all operations.

Duties and responsibilities position:

•  Assume full accountability for the quality of all company products, from development to final release.
• Ensure strict adherence to cGMP, internal SOPs, and all applicable regulatory and industry standards (e.g., FDA, ISO, EURO).
• Lead, manage, and mentor the Quality Assurance (QA) and Quality Control (QC) teams.
• Serve as the primary point of contact for all external audits (e.g., regulatory authorities, customers, and certification bodies).
• Lead the preparation, execution, and follow-up of regulatory inspections and third-party audits, ensuring timely and effective Corrective and Preventive Action implementation.
• Oversee internal audit programs and ensure continuous monitoring and improvement of quality systems.
• Coordinate with cross-functional teams (Production, R&D, Compliance, Logistics, Warehouse) to embed quality into all aspects of operations.
• Monitor quality KPIs and report on quality performance to Managing Director.
• Maintain and improve the Quality Management System (QMS), including document control, deviation handling, change control, complaints, and product release.
• Promote a quality culture across the organization through training, leadership, and example.

Requirements position:

• Master’s degree in Chemistry or Pharmacy required.
• Minimum of 3 years’ experience managing quality teams, preferably in the pharmaceutical industry.
• Deep understanding of cGMP regulations, pharmaceutical quality systems, and global regulatory requirements (e.g., FDA, ISO, EURO).
• Proven experience with regulatory inspections and external quality audits.
• Strong leadership and communication skills, with the ability to operate at both strategic and operational levels.
• High attention to detail, analytical thinking, and problem-solving ability.
• Leadership and decision-making.
• Regulatory compliance and inspection readiness.
• Cross-functional team collaboration.
• Risk management, Corrective and Preventive Action oversight.
• Strategic quality planning.
• Effective communication at all levels.