Blackfield Associates is collaborating with a leading pharmaceutical organisation to recruit an experienced Quality Director, Qualified Person to join their team. This pivotal leadership role is responsible for ensuring GMP compliance across operations, overseeing batch release for investigational and commercial medicinal products, and contributing to strategic business development initiatives.
Key Responsibilities:
* Serve as the Qualified Person, ensuring full adherence to GMP regulations and overseeing batch release for both investigational and commercial medicinal products.
* Manage and maintain the Quality Management System, including Quality Risk Management, CAPA, Change Control, and ensuring audit/inspection readiness.
* Support business development efforts by identifying growth opportunities, managing client projects, and collaborating with internal teams to achieve company goals.
* Lead internal and external audits, promote a strong culture of GMP compliance, and assist Senior Management in driving company vision and regulatory strategy.
The ideal candidate will have at least 8 years of experience in the pharmaceutical industry, with a comprehensive understanding of GMP quality systems. They must be eligible to act as a Qualified Person and possess a minimum of 5 years of QP experience, including work with Investigational Medicinal Products. Expertise in GMP regulations, QP responsibilities, and Quality Management Systems (including CAPA, Change Control, and Risk Management) is crucial. The role demands strong leadership, analytical problem-solving skills, and excellent communication abilities, along with the capacity to work effectively with cross-functional teams and external stakeholders.