Quality Manager - Aseptic Manufacturing Location: Bedfordshire
Salary: £60,000
Contract Type: Full-Time, Permanent
Are you an experienced quality professional with a strong background in aseptic manufacturing? We are seeking a proactive and knowledgeable Quality Manager to lead our quality operations and uphold the highest standards in the preparation of aseptically compounded medicines.
The Role In this key role, you will:
Lead and develop a high-performing, collaborative Quality team that reflects the values of our organisation
Oversee and manage the microbiology testing and environmental monitoring programme
Supervise batch releasing officers and quality control assistants to ensure consistent compliance and quality
Monitor quality performance, investigating trends in KPIs such as rework, complaints, and quality failures, and report findings to senior management
Promote good practice by supporting colleagues in understanding and applying GMP (Good Manufacturing Practice) standards
Support regulatory inspections, working alongside the Head of Quality Assurance to prepare for and close out MHRA and Home Office audits
Contribute to strategy, working with executive leadership to align the Quality function with regulatory requirements and business goals
Collaborate across departments, providing quality-related input for management reviews, new business tenders, and service development
To succeed in this role, you will have:
Proven experience in a similar quality role, ideally within an aseptic manufacturing environment
A degree in a life sciences subject such as pharmacy, microbiology, or chemistry
A minimum of 5 years GMP experience in a licensed facility or one operating under a section 10 exemption
Up-to-date knowledge of GMP standards and regulatory expectations
A self-motivated and confident approach to decision-making
Excellent interpersonal and communication skills, with the ability to engage colleagues at all levels
Strong IT skills, particularly with Microsoft Office applications
A recognised management qualification (desirable but not essential)
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