Job Reference: J5631411
Updated On: 13/05/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a Site Quality Manager to join a leading Science and Engineering company based in at their UK manufacturing site.
As the Site Quality Manager you will be responsible for the overall leadership of the Quality Team based in Devon. The Quality team hold ownership of all advice related to approval, regulatory compliance and all quality management related topics. As such the team guarantees that products are delivered with high quality and outstanding reliability.
The Site Quality Manager acts as a partner with suppliers, customers and internal stakeholders such as Operations, Sales, Purchasing, Strategic Sourcing, Engineering and R&D, both based locally and across all other Biotechnology sites.
Key Duties and ResponsibilitiesYour duties as the Site Quality Manager will be varied however the key duties and responsibilities are as follows:
1. Quality Management - Accountable for implementing quality performance targets and strategy, and managing Quality at the UK manufacturing site for base business under the direction and supervision of the International and Global Quality Leader Biotech Consumables.
2. Strategic - Develop specific Quality goals in line with Biotechnology Busniness Unit targets, Corporate polices and regional QM direction from . Responsible for identifying Quality considerations and communicating them to the International business QA lead.
3. Quality Assurance - Management of local QA for the site product portfolio, supervise quality related activities and quality control. Initiation of appropriate statistics for production control, responsible for investigations and resulting action plans plus approval of corrective / preventive actions.
4. Customer / Complaint Management - Accountable for execution of customer audits. Responsible for ensuring audit plan is set and conducted. Accountable as focal point for customer notifications, questions, complaints, documentation and certification requests related to products manufactured on site. As such, responsible for the timely response to those request and coordination of required information with other groups in the facility.
5. Supplier Management - Quality monitoring within supplier management program: Responsible to ensure compliance with Biotech standards and requirements, those are to be identified and communicated to the local procurement leader. Management of supplier related QA aspects.
6. Regulatory Affairs - Responsible and accountable for implementation of product specific legislation, RA requirements in the compliance programs, general requirements advised by Corporate QA&RA, and local/international legislative requirements for products made on site, with support from the RA Director.
Role RequirementsTo be successful in your application to this exciting opportunity as the Site Quality Manager we are looking to identify the following on your profile and past history:
1. Deep and current knowledge of Quality Management principles in Commercial and Manufacturing environments with associated industry and international regulations and standards required (cGMP) in the healthcare industry.
2. Working knowledge of Biotech industry related regulatory compliances and appropriate ISO standards
3. Proven success of building and leading a team and developing talent; demonstrated leadership capabilities outside of your direct team
4. Technical proficiency in Quality and Regulatory processes
5. Critical thinking and decision-making, analytical problem solving, business astuteness, and process orientation
6. Results oriented with the ability to balance other business considerations.
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