Job Description

Quality Manager/Responsible Person - Pharmaceuticals - Gloucester
Smart4 Sciences are proud to partner with an established and internationally recognised pharmaceutical company, renowned for their focus on the development, licensing and distribution of high-quality injectable medicines. With almost five decades of trusted service supplying the NHS, private healthcare, and global markets, they continue to lead in injectable and infusion therapies
We're now supporting them in hiring an experienced Quality Manager/Responsible Person (RP) to lead and continually improve the UK Quality Management System, uphold licence compliance, and embed GDP and ISO9001 best practice across their UK wholesale distribution operations.
Key Responsibilities:

• Manage and develop the UK Quality Management System (QMS) and eQMS, ensuring documentation, policies and procedures remain compliant and effective.
• Maintain WDA(H), GDP and ISO certifications; host regulatory inspections and manage responses through to closure.
• Oversee internal audits, supplier audits and self-inspections, driving continual improvement.
• Serve as an additional Responsible Person on the WDA(H) licence, ensuring ongoing compliance with GDP and regulatory expectations.
• Lead investigation, change control and CAPA activities, applying ICH Q9 Quality Risk Management principles.
• Champion GDP culture, deliver training, and promote quality awareness across the organisation.
• Manage quality complaints and communication with the MAH and customers.
• Monitor KPIs, trends, and supplier performance to drive data-led improvement.

About You:

• Strong background in pharmaceutical quality management, ideally within a WDA(H) environment.
• Comprehensive knowledge of MHRA GDP and ISO9001.
• Prior Responsible Person (RP) experience preferred (training can be provided).
• Skilled in inspection readiness, supplier qualification, risk management and continuous improvement.
• Confident communicator able to influence and promote quality culture across teams.

Why Apply?
This is an exciting opportunity to join a stable, growing organisation with a strong reputation for quality and integrity. You'll be given autonomy, professional development, and the chance to make a real impact on compliance and operational excellence across a respected UK pharmaceutical business.
To apply or learn more, contact Gareth Gooley @ Smart4 Sciences - specialists in permanent recruitment across Quality and Regulatory Affairs within the life sciences sector.

Skills Required