Quality and Regulatory Compliance Manager / Quality Manager
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Annual Salary: 50000 - 55000
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Location: Newtown, Powys
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Benefits package and a chance to develop your career wihtin a rapidly growing business
We are seeking a Quality and Regulatory Compliance Manager ensure the maintenance of an accredited Quality Management System and to grow the businesses already exceptional reputation for quality and service.
This is a senior management role, reporting to the UK Managing Director, will provide cohesion in leading and developing our Quality, Health & Safety, and Regulatory Teams, assuring compliance and continuous improvement.
Benefits for the Quality Manager
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Opportunity to lead and develop a critical department within the company.
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Be part of a company that values continuous improvement and compliance.
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Engage in a role that offers variety and the chance to work on multi-disciplinary procedures.
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With an established reputation in their specilist field, the company is on a strong financial footing and is capitalising on this to grow into new markets
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The have a world class facility and production capability.
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This role attracts a benefits package that includes life assurance and
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You will have several reports across different disciplines and be able to shape the futre culture and practices of the teams.
Required Skills & Qualifications for Quality Manager
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Proven management and development of an established team.
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Experience working to specialist quality standards, ideally ISO 13485.
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Experience supplying customers within regulatory critical environments.
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Utilisation of quality functions to drive sales and business reputation.
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Experience in a rapidly improving environment.
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Strong background in SQA, Root Cause Analysis, CAPA, and ensuring traceability, accountability, data, and process integrity.
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Familiarity with machine-led production to order.
Day-to-day of the role:
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Manage and develop direct reports within the Quality, Regulatory, and Health & Safety teams.
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Ensure the UK QMS meets all requirements of the business scope, as well as alignment with the corporate QMS.
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Monitor and interpret regulatory changes to assess their impact on the business.
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Oversee projects to implement quality and regulatory changes.
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Evaluate, identify, and remedy policies and procedures proactively.
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Contribute to assessments ensuring the integrity of policies and controls.
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Report on current, emerging, and thematic risks and issues at senior management level.
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Ensure organisational compliance with multidisciplinary procedures.
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Contribute to product reviews and new product creation to ensure product governance.
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Manage programs for measuring compliance and quality through key performance indicators.
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Represent the business during regulatory and client inspections/audits.
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Prepare site/operation personnel for audits and prepare summaries and reports.
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Coordinate the preparation of regulatory/client audit responses and corrective action commitments.
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Provide regulatory guidance with respect to data usage and ensure compliance with data protection legislation.
To apply for the Quality and Regulatory Compliance Manager position, please submit your CV a detailing your management achievements, experience in quality standards, and your approach to ensuring regulatory compliance.