QA & Compliance - Snr Manager - Remote / Dublin

3 weeks ago


Dublin, Dublin City, Ireland Cpl Healthcare Full time
QA & Compliance Senior Manager - Remote Opportunity

A biotech company focused on improving patient lives with rare diseases is seeking a Senior Manager to join their Quality Assurance team. This role offers a work-life balance, allowing you to work remotely or in our European headquarters in Dublin city centre.

To be considered, candidates must reside within the EU and hold a valid work permit.

Key Responsibilities:
  • Lead continuous improvement initiatives for Quality Management Systems and develop key GxP procedures.
  • Drive compliance across GxP functions, fostering a quality culture and ensuring timely closure of quality system records.
  • Establish and maintain an internal audit program, conducting self-inspections as scheduled.
  • Perform vendor audits as required.
  • Act as Deputy Responsible Person (DRP) for the Ireland WDA, ensuring license conditions are met.

Requirements:
  • Bachelor's Degree in sciences or equivalent required.
  • Minimum 10 years of pharmaceutical experience in QA Operations, Manufacturing, QC, and/or relevant operational areas required; GDP experience advantageous.
  • 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.


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