Director of Q.A. R.A. Ireland
As a member of the company's Senior Management Team, the Director of Q.A. R.A. Ireland will provide quality and regulatory management oversight for Ireland's licensed products.
The individual will be responsible for development assets, including the company's flagship program currently in Phase 3 clinical trials.
Support for diligence activities in respect of potential commercial or development stage product acquisitions will also be provided.
Key Responsibilities:
* Manage the team of Senior QA Managers based in Dublin.
* Implement and maintain a Quality Management System (QMS) that operates effectively with a range of third-party contractors' quality systems.
* Ensure the company is always inspection ready, including preparation for, participation in, and follow-up on inspections by regulatory authorities.
* Manage validation and stability programs.
* Day-to-day management of authorized activities, ensuring accuracy, quality, and maintenance of records.
* Ensure adherence to FDA/EU and local laws and regulations.
* Manage CMOs and sub-contractors, including vendor selection, approval of suppliers, and audits for GMP compliance.
* Lead Quality and Regulatory aspects of due diligence projects.
* Maintain appropriate Quality or Technical agreements with all GxP vendors.
* Develop, implement, and manage Pharmacovigilance, Medical Information, and Product Complaint processes and reporting.
* Ensure compliance of external sites to internal and regulatory guidelines.
* Minimize risks associated with compliance and quality.
* Apply the best quality standards to company products.
* Chair change control committees, product recall committees, and other ad-hoc committees as needed.
Requirements:
* NFQ Level 8 or preferably NFQ Level 9 degree in chemistry, biology, pharmacy, or a related discipline.
* Significant experience (15+ years) working in pharmaceutical finished product manufacturing with experience in compliance, quality assurance, quality control, and regulatory development.
* Experience interfacing with regulatory bodies and working on regulatory submissions.
* Thorough understanding of quality systems and cGMPs.
* Experience with and fundamental understanding of FDA regulations and guidance documents.
* Experience leading GMP audits, including drug product manufacturing and analytical testing sites.
* Process validation compliance.
* Knowledge of US device regulations would be an advantage.
* Experience defending processes, procedures, and investigation during regulatory inspections desirable.
* Professional written and oral communication skills, including presentation skills.