Quality Manager / Responsible Person – Pharmaceuticals – Gloucester
Smart4 Sciences is 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.
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 (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.
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