A biotech company focused on improving the lives of patients living with rare diseases, is now hiring a Senior Manager to lead their QA team. This role offers work-life balance and can be performed remotely or from our European HQ in Dublin city centre.
Job Description:
The Senior Manager QA Compliance is responsible for managing and leading improvements for our GxP Quality Management System. This role ensures that GxP activities are completed in alignment with Regulatory requirements, industry best practice, and company procedures.
* Lead continuous improvement initiatives for Quality Management Systems and author key GxP procedures
* Lead compliance initiatives across GxP functions, driving a quality culture and timely closure of quality system records
* Ensure an internal audit program is implemented and maintained, with self-inspections performed as scheduled
* Perform vendor audits as required
* Act as Deputy Responsible Person (DRP) for Ireland, ensuring the conditions of the license are met
Requirements:
* Minimum of a BS Degree in sciences or equivalent
* Minimum of ten years of pharmaceutical experience in QA Operations, Manufacturing, QC, and/or other relevant operational areas
* Experience supporting regulatory authority inspections and interfacing with regulatory authorities preferred
* Extensive knowledge of EU GDP and HPRA guidelines
* Knowledge of US, EU, ICH Regulations, guidelines, and requirements
About Us:
We are a biotech company dedicated to improving the lives of patients living with rare diseases.