QA & Compliance - Snr Manager - Remote / Dublin
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 a full EU work permit.
Responsibilities:
* 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 Deputy Responsible Person (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 is 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] #J-18808-Ljbffr