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UK Head of Quality
4 months ago
RRxCo is partnered with a leading Life Science Manufacturer in the search for a UK Head of Quality to support significant growth.
They are seeking an experienced leader to drive standards as a top-tier Life Sciences manufacturer.You will lead Quality advances across their team of 400 colleagues, build a dedicated Quality team in the United Kingdom (UK), and grow a culture of world-class quality.
DeliverablesnDevelop, implement and manage the Quality system and strategy, to ensure it meets the business requirements and customer deliverables.nLead, manage, and recruit an effective Quality team ensuring compliant and effective training and development.nChampion and work with the wider business to deliver and sustain ISO9001:2015.nBuild and refine a fit-for-purpose supplier assurance model whilst implementing effective risk management processes and tools.nIntroduce and mould a best-in-class Quality culture whilst maintaining and improving the effectiveness of the business.nSupport and lead as the Quality SME for internal business projects such as the building of a metrology laboratory.nEnsure the business maintains and improves regulatory readiness through organic growth and future acquisitions.nBe accountable and provide SME Quality advice whilst the business transitions into ISO13485 accreditation.nBuild and maintain strong relationships with the rest of the SLT and key stakeholders.nContinuous improvement and updating of the Quality Management System Framework and Strategies to ensure compliance with current regulatory requirements and alignment with the broader business plan.
Profile of IndividualnDegree (preferably Masters/PhD) or equivalent in Engineering, Chemistry/Life Sciences, or a related scientific/technical field.nExtensive years of relevant experience in Life Science/Medical Devices with experience in a supervisory/management role with demonstratable progression in managerial responsibilities.nIdeally knowledge/experience of complex products within instrumentation including software components/elements.nExpertise and proven working experience with current ISO9001:2015 and ISO13485 standards.nAbility to collaborate and influence across multi-functional teams and stakeholders.nExcellent verbal and written communication skills, and experience with technical writing including authoring and revising SOPs and technical reports.nFamiliar with working in a fast-paced complex environment, able to work flexible schedules.nIdeally, past or current experience working within a Life Science organisation (primarily a Medical Device organisation).nLead Auditor certification would be beneficial.nSix Sigma (minimum Green Belt) would be advantageous to support the continuous improvement journey.
