Quality Assurance Manager

Location: West Midlands
Salary: c£52k

The Quality Manager is responsible for the day-to-day management of a Quality Team within Healthcare. Reporting to the Head of Quality they will have a team of quality specialists and the responsibility of the quality management systems. The role is pivotal in ensuring compliance with Good Distribution Practice, ISO 9001, and ISO 13485 to ensure product quality and patient safety.

What are you going to be doing?

Day to day management of the Healthcare Quality team and the Quality Management System (QMS), to include 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 Healthcare to ensure compliance with Regulatory requirements, the company’s internal quality policies and meet customer expectations. The list of QMS elements includes 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" / be named on the WDA (H) licence.
Host audits for client and regulatory bodies.
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 every month.
Ensure the Healthcare Quality KPI data 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 in 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 on Quality/Technical Agreements with Clients and Suppliers, ensuring full compliance against these agreements.
Support the Arvato global Quality programme, document control, audits, and ensuring KPIs are tracked and monitored. Be a participant in Global QA meetings and ensure global actions are tracked and completed on time.

What are we looking for?
Someone who has experience in a Quality Management role, which includes:
Managing a team of people, along with all people management responsibilities.
Compiling and delivering Quality Management Training.
Effective Management of Quality Management Systems
Proficiency in using electronic Quality Management System
Conducting and reporting on regular audits and delivering the results to the Senior Management team.
Experience in ISO, GDP, Audits, CAPA, and complaint resolution.
Experience and management of risk management
Excellent communicator with exceptional organisation skills

You will have knowledge in:
MHRA Guidelines , GDP Legislation and relevant guidance (ie ICH Q9)
ISO 9001:2015 and ISO 13485:2016

What do we offer?
25 days annual leave with the option to purchase up to an additional 5 days.
Pension contribution
A life assurance policy that pays out 4 x Salary
Employee Assistance Programme that provides you with confidential support, information, and advice to help you.
Employee Discount Scheme through Treats