Head of Quality & Compliance

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Head of Quality & ComplianceI am currently working on an exciting Head of Quality & Compliance hire for a start up Pharmaceutical company in Birmingham (3 days a week on site required) who are looking for an experienced Quality Assurance leader to join the team on a permanent basis. This is an important executive hire for the business to help spearhead our GMP licence applications and development as a leading pharmaceutical business in a new, cutting-edge sector. We are currently mid-application for an API licence and will subsequently be applying for a Manufacturing Specials licence.For both of these, the individual will lead the team's efforts to be 'GMP ready' in an efficient manner. This will involve leading all quality executives and overseeing all GMP-related functions (eg, R&D), preparing all necessary documents for inspection and ensuring the facility, equipment etc is ready.This clearly requires deep GMP experience, but also experience in project managing a team to tight deadlines and planning ahead. As an early stage business, we have to deliver in an efficient timeline.Key Responsibilities:Lead on the regulatory MHRA, FDA and GMP compliance for all licence submissions (Manufacturing Specials initially) - including all correspondence with MHRA inspectors and mock auditorsProject manage the team to hit deadlinesLead, manage, support and develop the QA and QC teams to assure effective operational performance and complianceCreate the Departmental strategy objectives and goal settingLead on regular (daily) site walk-arounds to ensure GMP complianceOversee all GMP-related and QMS activities on day-to-day basisKey Requirements:20+ years experience in a Quality management role in Pharmaceuticals with deep understanding of both UK regulatory market (and US ideally):GMP (including MHRA inspections)Manufacturing SpecialsAPIsNatural medicinesExperience of leading a quality teamStrong project management skills (i.e, ability to drive team to meet deadlines as part of applications for licences)Understanding of MHRA (and ideally FDA in US) regulatory frameworksStrong knowledge of manufacturing drug substancesIf this Head of Quality & Compliance role in Birmingham looks as though it could be the next step in your Pharmaceuticals career, please get in touch ASAP! To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales