Do you want to be part of a fast-growing, globally recognised Scientific and Regulatory company?
If you do, we want to hear from you as we have an exciting Quality Manager role within our growing Quality Assurance team.
The Quality Manager is responsible for leading a team of Quality Officers who will ensure quality and compliance within Broughton Nicotine Services.
You will be responsible for managing all aspects of the quality management system building strong personal links and working closely with internal teams. You will have a strong understanding of the regulatory requirements and a thorough understanding of ISO 17025.
Main Purpose of job
* Manage the day to day quality management system (QMS) activities and approval of technical documentation
* To provide leadership and direction to the Quality Team and responsibility for the planning and forecasting of quality initiatives.
* Define, monitor, publish and present QA KPIs against business quality objectives and performance initiatives to members of the strategic management team (SMT).
* Conduct internal audits in accordance with approved schedules.
* Plan and execute improvement projects, both proactive and reactive to client and regulatory inspection findings.
* Hosting client audits, responding to findings and co-ordinating CAPA activities to meet deadlines set within the responses.
* Client communication on Quality related matters and collation and support of data requests from client including support for investigations.
* Manage the team responsible for supporting the operational laboratory investigations (Internal Non-Conformances, OOS/OOT, Complaints and complex CAPA) including root cause analysis, fish bone, minitab, statistical analysis and risk assessments.
* Be a subject matter expert (SME) for one or more areas within the QMS
Key person specificatio
* Preferred graduate of chemistry or analytical chemistry related subject.
* Good technical problem-solving skills.
* Good attention to detail.
* Good verbal reasoning and negotiating skills.
* Experience in an ISO 17025 regulated lab and working within a QMS (4+ years).
* Good IT skills including working knowledge of Microsoft applications.
* Results driven, customer focused and commercially astute.
* Experience of chromatography theory and practice.
* Experience of performing failure investigations and RCA (6+ years).
* Experience of data verification and reporting.
* Experience of training and developing others in a lab environment