QAagency is delighted to be working with an established pharmaceutical wholesaler and distribution company based in Bishop’s Stortford. The business provides pharmaceutical wholesale and third-party logistics services across multiple licensed warehouse facilities. They are now looking to recruit an experienced Quality Manager to oversee and continuously improve their Pharmaceutical Quality Management System (QMS), ensuring compliance with MHRA requirements, Good Distribution Practice (GDP) and other relevant pharmaceutical regulations.
As the Quality Manager, you will work closely with the Operations Director, Responsible Person and warehouse management teams to maintain regulatory compliance across the business. The role will involve managing the QMS, overseeing quality investigations, maintaining inspection readiness and supporting pharmaceutical wholesale, third-party customer and controlled drug activities. You will also be responsible for ensuring quality procedures are followed across all departments, promoting continuous improvement and maintaining strong relationships with customers and regulatory bodies.
- Manage and maintain the QMS, including deviations, CAPAs, change controls, risk assessments and SOPs.
- Coordinate internal audits, third-party logistics (3PL) audits and MHRA inspections, ensuring findings and corrective actions are addressed.
- Oversee customer complaints, quality investigations, supplier qualification and Quality Technical Agreements.
- Support GDP compliance across multiple warehouse facilities, including staff training, regulatory requirements and continuous improvement initiatives.
Key Requirements
- Minimum 3 years’ experience in pharmaceutical Quality Management, with a strong understanding of GDP and MHRA requirements.
- Experience managing deviations, CAPAs, SOPs, quality investigations and regulatory inspections.
- Knowledge of cannabis-based products for medicinal use (CBPM) and relevant pharmaceutical compliance requirements.
- Strong organisational, communication and problem-solving skills, with the ability to manage multiple priorities independently.
Previous experience working under an MHRA Wholesale Distribution Authorisation (WDA(H)) licence would be advantageous, along with knowledge of pharmaceutical 3PL operations, controlled drugs, cold-chain distribution and supplier qualification. A relevant degree or professional quality qualification would also be beneficial.
This is a full-time position based in Bishop’s Stortford, working 40 hours per week, Monday to Friday, 09:00 to 18:00. The role is primarily office-based with the flexibility to work from home one day per week.
Benefits
- 25 days annual leave plus bank holidays
- Group pension scheme
- Free on-site parking
- Free refreshments
- One day working from home per week