Quality Manager

Bestway Healthcare UK; Redditch; On-site; GBP 60,000 - 90,000; Full time

Job summary

Lexon, a UK pharmaceutical wholesaler, seeks an experienced Quality Manager to maintain GxP licences and drive quality assurance across Wholesale Specials and PI Repacking. The role requires robust regulatory compliance oversight, continuous improvement, and collaboration with operations to sustain a strong QMS.

The ideal candidate has extensive GxP experience, RP credentials, and a track record of leading quality teams within a fast-paced healthcare business.

Qualifications

• 2+ years in a GxP Quality role, preferably with licensed activity
• Experience as RP on a wholesale dealer license
• Experience managing quality staff
• Proficient with e-QMS/e-DMS tools

Responsibilities

• Implement and maintain the quality management system
• Manage authorized activities and records quality
• Ensure GDP/GMP training programmes are implemented
• Coordinate recalls for medicinal products
• Manage outsourced 3rd party relationships
• Lead Quality team members

Skills

GxP Quality experience

RP on wholesale license

Team leadership

Education

Cogent Gold standard RP training certification

RPi eligibility on WDA(H) regulations 45AA/45BAB

Tools

Q-Pulse

MasterControl

MFiles

Bizzmine

MS Word

Job description

At Lexon, quality and patient safety are at the heart of everything we do. As one of the UK's leading pharmaceutical wholesalers, we are looking for an experienced Quality Manager to support the maintenance, implementation and retention of the GxP licences that enable our business to operate and grow.

Supporting both our Wholesale Specials and Parallel Import (PI) Repacking operations, this is a pivotal role with broad exposure across a diverse pharmaceutical portfolio. You will be responsible for ensuring the highest standards of regulatory compliance, quality assurance and continuous improvement, working closely with operational teams to maintain a robust quality management system.

This opportunity would suit a quality professional with extensive GxP experience who thrives in a fast-paced environment and is looking to make a meaningful impact within a growing healthcare business.

Main Responsibilities

• Ensuring that a quality management system is implemented and maintained.
• Management of authorized activities and the accuracy and quality of records.
• Ensuring that initial and continuous GDP/GMP training programmes are implemented and maintained.
• Coordinating and promptly performing any recall operations for medicinal products.
• Management of outsourced 3rd party relationships and activities
• Management of Quality assistants to complete all Quality related tasks
• Promoting a positive Quality culture within the organisation
• Hosting and supporting MHRA and 3rd party inspection activity
• Management and completion of self-inspection activity
• Support and management of Qualification and Validation activity
• Preparation, support and attendance of Quality management and Product Quality reviews
• Management and investigation of Product Quality complaints
• Acting as Responsible Person as defined regulation 45 of the Human Medicines Regulations 2012 and EU Directive 2013/C 343/01

The Ideal Candidate

• Cogent Gold standard RP training certification
• A minimum of 2 years experience in a GxP Quality role, preferably dealing with the applicable licensed activity of the Bestway Healthcare organisation
• Previous experience as an RP on a wholesale dealers license
• Experience managing other Quality colleagues
• Proficient in Microsoft word applications and previous experience with e-QMS and e-DMS solutions (e.g. Q-Pulse, Bizzmine, Mastercontrol, MFiles
• Eligible to act as an RPi on a WDA(H) in line with the requirements of regulation 45AA and 45BAB of the Human Medicines Regulations 2012

Bestway Healthcare is proud to be a diverse and inclusive employer. If you have any specific requirements, we'll do everything we can to support you. Whether it is to find a pharmacy that is accessible, or if it is a part time position you are looking for, we can help find the role that is right for you. If you need us to make any reasonable adjustments to our recruitment process, we will be happy to accommodate you

Please be aware that due to the high number of applications we receive it may not be possible for us to provide an outcome to all applicants. If you are not contacted within 28 days of your submission unfortunately you will have been unsuccessful.