QA & Compliance – Senior Manager – Remote / Dublin
A biotech company focused on improving the lives of patients living with rare diseases, is now hiring a Senior Manager to join their QA team. With a focus on work life balance, you can work remotely or in our European HQ, in Dublin city centre.
Candidates must be resident with full EU work permit.
Responsibilities:
The Sr. Manager QA Compliance is responsible for managing and leading improvements for GxP Quality Management System. This role ensures GxP activities are completed in alignment with Regulatory requirements, industry best practice and company procedures. The role will lead continuous improvement initiatives for key GxP processes. The role will also be the Deputy Responsible Person (DRP) for Ireland.
• Lead continuous improvement initiatives for Quality Management Systems and authoring key GxP procedures
• Lead compliance initiatives across GxP functions, driving a quality culture and on time closure of quality system records
• Ensure an internal audit program is implemented and maintained and self-inspections are performed as scheduled
• Perform vendor audits as required
• Act as the DRP on the Ireland WDA ensuring the conditions of the license are met
Requirements:
• Minimum of a BS Degree in sciences or equivalent required.
• Minimum of ten (10) years of pharmaceutical experience in QA Operations, Manufacturing, QC and/or other relevant operational areas required, experience in GDP an advantage
• 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.
Apply:
Send CVs in confidence to [email protected]
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