Job DescriptionReporting to the Senior Quality Systems Manager/ Director of Quality Operations where your primary purpose is to lead professionals in the Quality Systems team.
Responsible for the oversight of compliance activities and systems for the site and for identifying opportunities for improvement within quality.Lead, mentor and develop a team of professionals in the Quality Systems Team to meet business needs and succession plans.Continuous Improvement Focus - Lead compliance improvements, which may result from Quality System Review trends and other groundbreaking projects.Drive robust quality and compliance execution in the business and drive successful Q&C scorecard metrics by working closely with key partners in the business.Encourage, support and direct initiatives and programmes that head to improved quality and improved regulatory compliance.Lead all Compliance activity within the facility in conjunction with the Regulatory Compliance and Quality Operations groups.
Liaise with management and produce metrics and present data on site performance at meetings such as the weekly and monthly management meetings.
Resolve potential compliance issues with functional Managers / Leaders.Lead the Corrective Action and Preventive Action system so this it is maintained in a manner compliant with local and WW procedures, ISO, QSR and Corporate Requirements.Lead the Non-conformance (NC) system so that it is maintained in a manner compliant with local and WW procedures and ISO and QSR and Corporate Requirements.Run the Customer Complaints process collaborating with Complaints and Vigilance teams ensuring that timely closure is met whilst fully satisfying all Customer Complaint requirements.Continue to develop strong working relationships at all levels of the business both internally and externally and ensure that the training needs of the site end users are met.Ensure that there are sufficient resources available to support activities such as non-sterile release or Device History Record (DHR) review prior to QA Release and for the co-ordination of DHR archiving activities at the site in compliance with the records retention policy.Ensure that the Quality System Review (QSR) continues to develop in terms of inputs and to ensure that any trends noted at this forum are challenged and acted upon.Support and chair the Quarterly Quality Management System Review in terms of preparation for these meetings and ensuring that any trends/ issues noted are challenged and acted upon.Support the internal audit system to both local procedures and other regulations and standards as outlined in SEP-180.Support the unannounced audit preparedness process and ensure that there are resources available to support external regulatory audits and inspections.Assist the Quality Operations teams in the management of regulatory compliance program to include FDA and BSI regulations.Partner with other company sites/ operating companies to ensure harmonization and alignment with company Quality Policies, Guidelines, Programmes and Systems.Ensure compliance with all regulatory requirements as outlined in SEP-180.Drive proactive Quality such as involvement in CMMI assessments and Recall Reduction initiativesMaintain a high level of housekeeping in designated areas and observe all HS&E requirements.Operate within the company's standard operating procedures where applicable, review, maintain and create appropriate procedures for sphere of activity.Requirements A degree level or similar qualification in a science, mechanical or industrial engineering discipline.Minimum 5 years' experience in a senior quality role within a regulated industry with a minimum of 2 years' experience in a leadership position.Shown ability to successfully deliver projects and key site Quality initiatives.Extensive knowledge of FDA, ISO and MDD GMP requirements regarding medical devicesPackageSalary negotiable
