Head of QA

Hobson Prior are seeking Head of QA to join a blood and cell technology organisation on a permanent basis. This role will be located in northern Ireland.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Accountable as Legal Manufacturer, as appropriate, for specific products (as applicable).
• Support manufacturing to produce products, improve product and process quality through the use of quality management techniques, such as First Time Quality initiatives; identify and drive improvement projects to either gain efficiency, improve product quality or cost down.
• Oversee and manage NC process and root cause investigation. Work with cross functional team to drive improvements to reduce NCs.
• Manage throughput and backlog of inventory in incoming and final inspections, and staff/schedule accordingly.
• Collaborate with Supply Chain function to monitor and manage quality across supply chain.
• Run Operations/Manufacturing QA/QC and their leadership, calibration, receiving quality assurance (RQA), and other operations quality functions as required.
• Operations Quality areas of ownership, management, and responsibility may include (as assigned): Incoming product testing, QC in-process testing, Product Quality and Continuous Improvement, Production and Process Controls, Non-conformance investigation and controls, Product Release, Supplier management, CAPA, Audit (internal, external, supplier), Quality System Training, Document Control, Management Review, etc.
• Serves as expert and main point of contact for regulatory issues within area of responsibility.
• Acts as the policy owner for area(s) of responsibility, ensuring they are compliant and effective.
• Performs their QMS area in accordance with governing internal policies and external standards and regulations.
• Monitors the health of the QMS areas within their area of responsibility, and provides metrics to management as required, including any governing oversight boards.
• Serves as Subject Matter Expert and Process Owner for their QMS area of responsibility during audits and inspections.
• Influences the organization in quality objectives, prioritization and resourcing decisions as necessary.
• Manages and provides operational leadership for the functional group's development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• During audits and inspections, interfaces with global regulatory authority, notified body auditors and provides general support for the Quality group.
• Interfaces with QMS area owners and project teams from other locations, regions, and corporate.
• Confirm that the Quality system is updated and maintained to the current GMP as required by European and American regulatory authorities, ISO 9001, and ISO 13485 and MDSAP.

Requirements:

• At minimum, Degree in a Life Science - or a closely related subject.
• Minimum 5 years' experience in a similar senior role within a Medical Device, Pharmaceutical Manufacturing or relevant Regulatory field.
• Minimum 5 years' experience in Document Control, Risk Assessment within a Medical Device, Pharmaceutical Manufacturing or relevant Regulatory field.
• Strong Management Skills
• Preferred training in FDA Quality System Regulation and ISO 13485.
• Experienced in leading audit responses to various notified bodies.

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.