Director of Quality Assurance QP
On-siteInveran, Connacht, Ireland
Job Summary
Support and lead the Qualified Persons (QP), providing strategic and operational leadership to the Batch Release and Investigations/CAPA teams while ensuring all drug products meet internal standards and cGMP regulations. Direct quality oversight of product release processes, change control, CAPA, deviation management, and risk assessments, and oversee the implementation of the Quality Management System (QMS). Lead inspections and audits by regulatory authorities, manage documentation control including batch records and SOPs, and collaborate cross-functionally with Manufacturing, Packaging, and Regulatory Affairs. Monitor and report quality metrics to senior leadership, driving data-informed decision-making and fostering a culture of accountability and continuous improvement within the QA organization.
Required Qualifications
- QP certified
- Bachelor's of Science (Pharmacy, Chemistry, Microbiology or related field)
- Strong understanding of Annex I, US, and EMA GMP regulations
- Practical experience in regulatory audits
- Aseptic manufacturing expertise
- Proven experience in contamination control strategies
- Extensive experience in the pharmaceutical industry
- Strong understanding of sterile drug manufacture and cGMP requirements
- Demonstrated ability to manage multiple strategic and operational priorities in a fast paced environment
- Strong problem solving and critical thinking skills
- Excellent communication, writing, presentation and data organisation skills
- Demonstrated interpersonal and leadership qualities
Desired Qualifications
- Advanced degree (M.S., Ph.D., MBA)
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