Hobson Prior are currently working with a gene therapy organisation who are determined to develop possible curative treatments for patients who are living with serious illnesses. This innovative company is seeking a Head of Quality to join them on a permanent basis in Ireland.

Job Responsibilities:

• You will work closely with the Head of Engineering and the Manufacturing Lead to set up all operational aspects of the site quality systems ensuring GMP compliance and full integration with the organisation's global quality system.
• Accountable to lead the process with the relevant regulatory authorities to gain the necessary site licence approvals for product manufacture.
• Once the site is fully operational, provide strong leadership and end-to-end QA oversight of the manufacturing facility and quality support functions ensuring that all products are manufactured in accordance with the site licences and that all associated quality documentation is reviewed and approved in compliance with internal and external cGMP requirements.

Key Skills:

• Ability to make sound decisions regarding evaluation of GMP compliance, and leadership abilities in the management of QA oversight.
• Proven ability to work in an ambitious, deadline-driven environment and handle multiple projects simultaneously.
• A track record of recruiting, developing and leading high-performance teams.
• Must be a team player prepared to lead, work in and embrace a team-based collaborative culture.

Requirements:

• BSC/MSC/PhD in a Science discipline.
• Extensive knowledge and understanding of pharmaceutical Quality Assurance and GMP experience within a manufacturing stat up project.
• Strong knowledge and understanding of all aspects relating to building a sterile manufacturing site from concept design through to commercialisation.
• Minimum 5 years' experience executing validation activities and with and implementing the concepts, legislation, guidelines and requirements related to qualification and validation of products, processes, equipment and systems, including Computer System Validation e.g. EU/FDA GMP guidelines, EU Annex 15, PIC/S & GAMP guidelines, CPV, EU Annex 11 & CFR Part 11 and ICH Q9
• Extensive Operational knowledge of GMP Operations and Quality Systems required for a sterile manufacturing facility applying and understanding of the principles of sterile manufacturing as defined in "Annex 1".
• Eligible to act as a 'Qualified Person' as defined in 2001/83/EC and 2001/82/EC (as amended), is preferable but not essential.
• Strong working knowledge of the principles and guidelines for GMP as set out in the Orange Guide, Eudralex Volume 4, U.S. 21CFR part 210/211 and other relevant regulations.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.