Quality Manager

Wells & Co.; Redditch; On-site; GBP 60,000 - 90,000; Full time

Job summary

Wells & Co. in the United Kingdom is seeking an experienced Quality Manager to lead the GxP quality function for Wholesale Specials and Parallel Import operations. This role requires strong regulatory compliance, QA, and continuous improvement expertise within a fast-paced healthcare business.

You will implement and maintain the Quality Management System, manage training, recalls, and third-party relationships, and mentor Quality staff while supporting MHRA inspections and internal reviews.

Qualifications

• Minimum 2 years in a GxP quality role.
• Experience as RP on wholesale dealer license.
• Experience managing quality colleagues.
• Proficient with MS Word and e-QMS/e-DMS tools (Q-Pulse, Bizzmine, Mastercontrol, MFiles).

Responsibilities

• Ensure 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 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.
• Cogent Gold standard RP training certification

Skills

GxP experience

RP training

Quality management

Regulatory compliance

Training programmes

Record keeping

Tools

Q-Pulse

Bizzmine

MasterControl

MFiles

Job description

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.,

• 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 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., 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

Desirable:

• Eligible to act as an RPi on a WDA(H) in line with the requirements of regulation 45AA and 45BB of the Human Medicines Regulations 2012 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., With the purpose of improving the lives of our patients and customers, Bestway Healthcare supports communities across the United Kingdom and Ireland through an extensive network of community pharmacies and pharmaceutical wholesale depots.
• Our wholesale business unit operates two pharmaceutical wholesale brands, Lexon and Bestway Medhub which combined support over 5,000 independent community pharmacy contractors, processing over 100m packs of medication every year making us the 4th largest pharmaceutical wholesaler in the United Kingdom. Our wholesale business unit also operates a leading appliance wholesaler, Wardle's, a generic supplier Key Pharmaceuticals. We operate from 3 distribution centres with a fleet of vans delivering to independent pharmacies & directly to the most vulnerable patients every day.