Quality Lead (Quality & Technical compliance) - available immediately
One of my top clients based in the South East of England is now looking for a Quality Lead of Quality and Technical Compliance to join their team on a full time basis. This role has gone live due to the company expanding their internal quality team. The company has a portfolio in Medical Devices, Pharmaceuticals etc and brands itself as a healthcare company with an international presence. More details about the company provided on application. The main function of this role would be to lead all aspects of CMC post-marketing quality & technical compliance for the companies' pharmaceutical and embolic products. These responsibilities include: - Being team lead for preparation, collation and review of all relevant information for submission to Regulatory Authorities in line with deadlines set - Assess the impact of proposed manufacturing changes to make sure they are in compliance with regulatory licences - Assisting with post marketing changes to ensure that the regulatory strategy is aligned with project and business objectives - Prepare and maintain submission documents for licensed products - this involves the collection, review and combination of scientific, medical, and other supporting documentation into submission dossiers - Be in charge of local submission tracking and document control duties - Manage annual product quality reviews in line with SOPs for licensed pharmaceutical products - Be part of the site change control review board and CAPA board as needed - Other duties as instructed by senior management For this position, the successful candidate will need: - Degree or equivalent level in life sciences subject - A relevant level of experience within the pharmaceutical industry in quality or regulatory role (5 years ideally) - MHRA, Health Canada and FDA regulation experience This role offers a very generous base salary of £45,000.00 - £48,000.00 and a standard benefits package. Although this is an urgent vacancy (and if it matches your profile you should apply now) we also have other opportunities with this company and this role, so please feel free to send a CV through so that we can discuss these roles too.