Employer profile
NuVision (www.nu-vision.co.uk) is a leading UK wound care company, committed to developing and commercialising innovative high quality human tissue products. Our launch focus is Ophthalmology, helping to save sight through treating ocular surface indications. However, our future aim is to expand into wider wound care. NuVision clean room clinical manufacturing laboratories, licenced by the Human Tissue Authority (HTA) and offices are based at MediCity, Boots Enterprise Zone in Nottingham.
What we are looking for:
NuVision is now looking for an exceptional and committed Quality Manager to lead the quality department. The role will be based in the MediCity facilities. The successful candidate will oversee the quality and regulatory compliance of NuVision Biotherapies activities, including the manufacture and distribution of Tereo Processed Amnion Membrane (Omnigen), with Human Tissue Authority regulations, whilst contributing to the day-to-day Quality administration requirements of our clean room manufacturing facilities.
This is a permanent role starting as soon as possible and includes a 3-month probationary period.
Key responsibilities
- Leadership of the Company Quality Function and the ongoing development and improvement of NuVision’s Quality Management System
- Planning and delivery of all Quality Management activities across all company functions
- Management and development of a small and growing department
- Coaching and development of all direct reports to fulfil their potential in an expanding company
- Training and Coaching of all company employees to ensure that quality and regulatory compliance is in built throughout the organisation
- Fulfil the role of Person Designate in accordance with the requirements of the Human Tissue Authority, assisting the company’s Designated Individual in ensuring that all relevant activities are conducted in compliance with HTA regulations.
- Quality Assurance in all manufacturing operations through established procedures for:
- LOT/Batch records review and QA release
- Routine Environmental testing of all facilities and utilities
- Receipt, Review & File of Testing Results
- Maintenance and calibration of all plant and equipment
- Developing and managing audit procedures for internal and external supplier audits
- Maintaining demonstrated compliance through successful outcomes in external audits by regulatory authorities and notified bodies
- Maintenance and development of document control, training, customer complaints, NC, and CAPA processes and procedures
- Lead and develop Risk and safety Management activities
- Organising, chairing and documenting regular company-wide Quality meetings.
- Organising company Management with Executive responsibility meetings to verify that all operations are in control
- Lead or Support all relevant company projects.
Candidate profile
· Minimum 5 years’ experience working in Quality and Regulatory roles within medical devices.
· Knowledge/experience of Human Tissue Authority regulations. (Desirable)
· Good communication skills, in person and electronically.
Salary and Benefits: A competitive salary and benefits package reflecting the importance of this role to the company’s development
Please follow the link to a apply: https://uk.indeed.com/viewjob?t=quality+manager&jk=ee08832a143d126b&_ga=2.21325243.1068213137.1639490731-266985240.1639127493&_gac=1.47276373.1639127493.CjwKCAiAksyNBhAPEiwAlDBeLMalBHHvMelZQwgetDPuyQ4fTEWn2pReY-OfZnUi9AT6Rjsy4z60kxoCA3YQAvD_BwE
