Quality Manager

Location: Ash Green

Company description:
Bertelsmann is a media, services and education company that operates in about 50 countries around the world. It includes the broadcaster RTL Group, the trade book publisher Penguin Random House, the magazine publisher Gruner  Jahr, the music company BMG, the service provider Arvato, the Bertelsmann Printing Group, the Bertelsmann Education Group, and Bertelsmann Investments, an international network of funds. The company has 117,000 employees and generated revenues of €17.1 billion in the 2015 financial year.

Bertelsmann stands for creativity and entrepreneurship. This combination promotes first-class media content and innovative service solutions that inspire customers around the world

Job description:

Salary:
Up to £53,000

Location:

East Midlands Gateway/ Kings Norton, Birmingham

Hours:

40 hours per week, Monday to Friday Are you passionate about delivering high-quality services and driving continuous improvement? Were looking for a Healthcare Quality Manager to join our growing Quality team  this role, youll take the lead on quality assurance across two key sites, ensuring compliance with healthcare standards while supporting operational excellence. The Quality Manager is responsible for the day-to-day management of the Healthcare quality team and the Quality Management System (QMS).

Understanding the Healthcare client's quality needs and requirements to develop effective processes to ensure agreements are adhered to and ensure continuous improvement. Fostering a culture of compliance to Good Distribution Practice (GDP), ISO 9001, and ISO 13485 to ensure product quality and patient safety. Your tasks Leading and managing and team to achieve and exceed quality results and SLAs. People management activities Day-to-day management of the Healthcare Quality team and the Quality Management System (QMS).

Compliance First - Prioritise full compliance with GDP and ISO requirements to ensure Patient Safety and product quality. Support the Head of QA with the development, management, and maintenance of all elements of the Quality Management System (QMS) within Arvato to ensure compliance with Regulatory requirements and, companys internal quality policies and meet customer expectations. The nonexhaustive list of QMS elements include Deviations and CAPA Management, Internal Audits, Change Control, Document control, Training, Audits, Temperature Management, Supplier Management, Quality Risk Management, Validation, Qualification & Calibration, Returns and Recalls, Pest Control etc.

Act as a delegate for the "Responsible Person" / named on the WDA (H) licence as a deputy. Host audits for client and regulatory bodies with support from the Responsible Person. Support the training of colleagues within Healthcare by designing relevant training packs on quality topic workshops Create a strong and effective working relationship with colleagues in all relevant operational and functional roles to ensure full commitment and support to clients Quality Agendas.

Raise Quality and Compliance awareness across operational and non-operational teams and functions in line with GDP and ISO requirements. Ensure contractual KPIs are monitored, reviewed, and achieved on a monthly basis. Ensure the Quality KPI data for the Healthcare Quality and compliance for client and Arvato business review meetings is completed and where applicable present these in the assigned meetings.

Work with internal departments to collate information for the Annual Quality Review and host the meeting with the Head of Quality. Advise and assist all operational and non-operational departments (within their area of responsibilities) on quality standards and regulatory requirements and issues. Support business growth by advising and participating on healthcare projects from a Quality and Regulatory point of view.

Ensure harmonisation of best (GDP/ISO) practices are rolled out across all Arvato UK Healthcare sites and business units in conjunction with the rest of the Quality Management team and middle and senior management. Review and agree Quality/Technical Agreements with Clients and Suppliers, ensuring full compliance against these…