GxP Quality Manager & RP Compliance Lead

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

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.