We are seeking a visionary leader to spearhead our Quality Assurance efforts, driving operational excellence and strategic growth across the organization.
The Director of Quality Assurance will be responsible for leading two critical teams: Batch Release and Investigations/CAPA. This individual will provide strategic guidance, develop strong decision-makers, and foster a culture of accountability, collaboration, and quality excellence.
Key Responsibilities:
* Provide strategic and operational leadership to the Batch Release and Investigations/CAPA teams
* Align with corporate objectives and global regulatory standards (FDA, HPRA, etc.)
* Manage team activities, develop strong decision-makers, and mentor site leaders
* Direct quality oversight of product release processes, change control, CAPA, deviation management, and risk assessments
* Oversee the implementation and maintenance of the Quality Management System (QMS)
* Lead inspections and audits by regulatory authorities and ensure audit readiness at all times
* Manage self-inspection programs, driving continuous improvement initiatives in QA systems and processes
* Ensure robust documentation control, including management of batch records, standard operating procedures (SOPs), and quality manuals
Requirements:
* Bachelor's degree in Pharmacy, Chemistry, Microbiology, or related field; Advanced degree preferred
* Regulatory knowledge: Strong understanding of Annex I, US, and EMA GMP regulations
* Aseptic manufacturing expertise, proven experience in contamination control strategies
* Minimum 10 years of experience in the pharmaceutical industry with a strong understanding of sterile drug manufacture and cGMP requirements
* Demonstrated ability to manage multiple strategic and operational priorities in a fast-paced environment