QA Director (Pharmaceutical)

We are looking for an experienced QA Director to lead the Quality Assurance function for a pharmaceutical manufacturing organization operating within a highly regulated environment.

The successful candidate will provide strong leadership in QA operations, quality systems, regulatory compliance, inspection readiness, and quality decision-making, while serving as a key advisor to the management team and providing clear direction to the QA organization.

Key Responsibilities

• Lead and oversee the Quality Assurance function, ensuring effective implementation and continuous improvement of the company's quality management systems.
• Provide day-to-day leadership, technical guidance, and decision-making support to the QA team.
• Take a leading role in regulatory inspections and audits, including preparation, hosting, response management, and follow-up activities.
• Ensure compliance with applicable GxP requirements, regulatory standards, GMP, and internal quality policies.
• Manage and continuously improve QA systems, including deviations, CAPA, change control, complaints, investigations, quality risk management, and related quality processes.
• Provide timely and sound quality decisions and guidance on operational and compliance matters.
• Partner closely with Manufacturing, QC, Engineering, R&D, Regulatory Affairs, and other functions to ensure quality requirements are effectively integrated into daily operations.
• Lead and develop the QA organization, building a strong quality culture, accountability, and technical capabilities within the team.
• Support management in assessing quality and compliance risks and defining appropriate mitigation and improvement strategies.
• Ensure inspection readiness and maintain a high level of regulatory compliance across manufacturing and quality operations.

Requirements

• Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related scientific discipline.
• 7+ years of experience in managerial or senior managerial QA positions within highly regulated pharmaceutical or life sciences environments.
• Strong hands-on experience in QA operations, quality systems, and regulatory inspections, with demonstrated ability to lead inspections and manage regulatory interactions.
• Solid experience working with different pharmaceutical manufacturing processes and dosage-form operations, preferably including both non-sterile and sterile manufacturing environments.
• Experience in organizations operating under US FDA and/or EU regulatory requirements is highly preferred.
• Strong knowledge of GMP, quality management systems, inspection readiness, deviation/CAPA management, change control, and risk management.
• Proven leadership capability with strong judgment and the ability to make quality decisions and provide practical guidance in daily operations.
• Strong communication and stakeholder management skills, with the ability to work effectively across functions and levels of the organization.
• Good command of English, both written and spoken.