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.
Deliverables
* Develop, implement and manage the Quality system and strategy, to ensure it meets the business requirements and customer deliverables.
* Lead, manage, and recruit an effective Quality team ensuring compliant and effective training and development.
* Champion and work with the wider business to deliver and sustain ISO9001:2015.
* Build and refine a fit-for-purpose supplier assurance model whilst implementing effective risk management processes and tools.
* Introduce and mould a best-in-class Quality culture whilst maintaining and improving the effectiveness of the business.
* Support and lead as the Quality SME for internal business projects such as the building of a metrology laboratory.
* Ensure the business maintains and improves regulatory readiness through organic growth and future acquisitions.
* Be accountable and provide SME Quality advice whilst the business transitions into ISO13485 accreditation.
* Build and maintain strong relationships with the rest of the SLT and key stakeholders.
* Continuous 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 Individual
* Degree (preferably Masters/PhD) or equivalent in Engineering, Chemistry/Life Sciences, or a related scientific/technical field.
* Extensive years of relevant experience in Life Science/Medical Devices with experience in a supervisory/management role with demonstratable progression in managerial responsibilities.
* Ideally knowledge/experience of complex products within instrumentation including software components/elements.
* Expertise and proven working experience with current ISO9001:2015 and ISO13485 standards.
* Ability to collaborate and influence across multi-functional teams and stakeholders.
* Excellent verbal and written communication skills, and experience with technical writing including authoring and revising SOPs and technical reports.
* Familiar with working in a fast-paced complex environment, able to work flexible schedules.
* Ideally, past or current experience working within a Life Science organisation (primarily a Medical Device organisation).
* Lead Auditor certification would be beneficial.
* Six Sigma (minimum Green Belt) would be advantageous to support the continuous improvement journey.