Head of QA (remote-based)
- Experience Level
A fantastic vacancy has become available for a Head of QA to work remotely for a drug discovery and development organisation focused mainly on Severe Asthma & COPD. If this is something you are interested in, please get in touch now!
Please note that to be considered for this role you must have the right to work in this location.
- Accountable to develop and implement the Quality Policies and procedures to ensure appropriate operation of the Company and assure compliance with EU, US and ROW for development and commercial regulatory requirements.
- To develop, establish and maintain the QMS to support drug development activities, clinical and commercial manufacture and supply recognising opportunities for continuous improvement to meet global GxP regulatory requirements.
- Ensure Quality activities incorporate the specific requirements for the manufacture and supply of biological pharmaceutical products, including aseptic manufacturing practices, and the administration of drug products using appropriate and approved medical devices.
- Understand the regulatory framework in the EU, US and ROW for manufacturing, commercial launch and product supply.
- Implement and oversee the commercial supply chain from a quality perspective employing the use of GxP approved contractors and vendors.
- To represent as the Responsible Person as required by the EU GDP Guidelines and safeguard product users against potential hazards arising from poor distribution practices.
- Prepare, implement and maintain the Company Quality Manual assuring it reflects Company activities and meets regulatory requirements.
- Act as the main point of contact for all GMP/GDP Quality activities internally and externally.
- Coordinate and oversee all regulatory inspections related to the Product supply chain, host internal inspections as required.
- Implement routine documented management reviews of the Quality system, identifying and assessing operations against agreed and appropriate KPIs, and identifying and applying improvements where required.
- Ensure customer quality requirements are achieved.
- Accountable for the coordination of Product complaints, investigations and Product recalls including the notification and interaction with regulatory agencies as required.
- Any other assigned duties.
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.