Job Description
A Head of Quality Assurance is required to work with our Dublin-based pharmaceutical client. The successful candidate will lead and mentor the QA Operations team to deliver excellence in quality and compliance.
Key Responsibilities:
* Lead the QA Operations team, ensuring they operate independently and cohesively to achieve quality and compliance objectives.
* Provide technical expertise on all QA and compliance topics related to manufacturing and product supply.
* Serve as the quality point person, providing guidance and feedback on quality assurance issues.
* Ensure timely review and approval of documentation, investigations, and reports, highlighting and assisting in the resolution of issues based on risk level.
* Oversee the application of Risk Management Principles at the facility.
* Maintain schedules for the approval of GMP documents to meet Commercial Operations needs.
* Provide comprehensive QA support to manufacturing, engineering, utilities, supply chain, and material movement (including cold chain) for commercial products.
Requirements:
* QP qualification highly desired.
* 15 years of relevant experience in the pharma industry or a related field.
* 3 years of managerial experience.
* Aseptic manufacturing experience is essential.
* Knowledge of cGMP requirements for pharmaceutical manufacturing required.