Description
After a large investment in to their compliance department my client is now looking to take on a Site Compliance Manager £40,000- £48,000 to ensure that the businesses compliance is maintained throughout their future growth.Reporting to the Head of Compliance, the Site compliance Manager will be directly responsible for managing Cardiff facility compliance activities ensuring the business plan and growth strategy are supported by ensuring business objectives are achieved and customer expectations are exceeded.
Major Functions & objectives include;
- Effectively lead and manage the team of personnel (QA/RA/QC) ensuring team and department objectives and KPI's are set and aligned with the business objectives and are achieved as per plan and any issues are dealt with efficiently and effectively following site procedure
- Successfully prepare for and host external body audits (Notified Bodies, Competent Authorities, Customers) ensuring Cardiff facility certification / compliance continuation and actively promoting a standard of excellence within the business
- Set within agreed timescales and managing budget and CAPEX control of QA, QC, H&S and other compliance activity
- Pro-actively monitor regulation ensuring Cardiff facility remains compliant to regulatory changes and non-compliance failure cost is minimised (QMS, Import/export, H&S, Environment etc)
- Actively support R&D, NPD, Operations and product transfer as a technical support and compliance representative
- Must have ability to communicate effectively with all level of management, suppliers and customers to agree solutions / actions and manage improvement / compliance activity
- Champion compliance throughout the facility by promoting best practices and changing pre-determined opinions through training, mentoring and assisting other department achieving business objectives
- Confident in their decision making ability and getting the point across when needed to other site management members, Head of Compliance and Managing Director
Essential Requirements;
- Management representative for Cardiff facility for compliance activities e.g. ISO13485:2003, ISO9001:2008, 21CFR820 and ANVISA etc.
- Monitor, measure and manage site compliance activity e.g. validation, calibration, internal audits, H&S, environmental etc
- Manage and maintain Cardiff facility QMS and other site compliance management systems such as H&S, Environmental
- Prepare, organise and manage Management Review meetings including follow up activity for quality, H&S, Environmental etc
- Successfully host external body audits (Notified Body, ANVISA, Customers) ensuring Cardiff facility certification / compliance continuation and responding to any identified non-conformities with an improvement action plan within agreed timescales
- Must have working knowledge of H&S regulation, environmental regulation and other compliance associated legislation
- Must be able to develop and implement training programs for other personnel and departments based on Cardiff facility requirements (QMS, H&S, regulatory compliance etc)
If you believe that you have the right experience for this position then please forward me your CV and I will be in touch shortly to discuss further.