Hobson Prior is currently recruiting for a Quality Manager - CMO to be based in Dublin. The position is with a large pharmaceutical company who are determined to deliver pioneering medicines to enable better health for patients around the world.

Job Responsibilities:

• Act as the Quality contact for CMOs maintaining oversight at those cmos for Quality related topics.
• Prepare for and attend relevant CMO governance meetings and internal company meetings.
• You will be the Quality representative on the External Supply team and will work collaboratively with the cross functional team and CMO to facilitate supply of product to their patients.
• You will be required to resolves quality related topics and escalate where further input is required.
• You will be our Quality contact/approver for Quality documents, for example, change controls, deviations, capas, validation documents related to cmos and you will be the Quality approver for CTL documents.
• Maintain and improve CMO quality metrics that incorporate continuous improvement methodologies and where necessary, you will support internal audits and Health Authority inspections as required.
• You will review and approval of CMO documents.
• Provide evaluation of CMO's Quality Management Systems to ensure appropriate level and content of reporting, including technical evaluation of quality system reports.
• You will work in collaboration with the Disposition team, Quality teams and cross functionally with external supply, planning, technical and other stakeholders including CMO partners.

Key Skills:

• Interpersonal skills and communication skills to interact with CMO partners and other functions.
• Must be able to prioritize in a busy environment.
• Must be available to travel -approx 20% (domestic and international).

Requirements:

• In-depth understanding of quality systems and cGMPs.
• Experience conducting audits and/or involvement in preparation for Health Authority inspections.
• A minimum of 8 years' + experience working in manufacturing and/or Quality to support the manufacturing of biologic products.
• Strong technical/Quality background with specific experience in Biologics manufacture.
• manufacturing site experience and CMO oversight experience would be valuable.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.