Senior Quality Assurance Manager (CMO)
Remote
RK4280
12 Months
Dublin


We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Duties:

• Be an integral quality member of cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain XPD etc.
• Negotiator and Approver of quality agreements
• Lead the preparation of the site for and Represent at product-specific Regulatory Inspections and/or during Notified Body audits of CM Site, as applicable or required.
• Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas
• Review / Approve Master Batch Records
• Quality approver for deviations, change controls, CAPA
• Prepare inspection playbooks
• Identify and mitigate Risk at the CMO or testing Laboratories and/or escalate to management
• Perform Person in Plant activities as required
• APR Data Provider
• Manage Audit commitments to completion
• Perform tactical batch disposition activities in support of lot release

• Bachelor’s degree in a Science related field is required.
• 10 + years biotech or pharmaceutical industry experience
• Significant Quality experience at Aseptic Manufacturing facilities
• Have a good oversight of deviation management, reg affairs, filings, regulatory, the guidance, e.g., HPRA requirements, so a very broad experience in quality.
• Previously worked in an external manufacturing environment.