QARA Manager

Bis Henderson; Ringway; On-site; GBP 50,000 - 55,000; Full time

Job summary

A leading recruitment agency is seeking an experienced Quality Assurance & Regulatory Affairs (QARA) Manager to lead the Quality Management System and ensure regulatory compliance within a pharmaceutical distribution environment. The ideal candidate will have over 5 years of experience in quality assurance, strong leadership skills, and a thorough understanding of UK and European compliance regulations. This position offers a competitive salary in the UK and requires an unrestricted right to work.

Qualifications

• 5+ years' experience in Quality Assurance and Regulatory Affairs.
• Experience in a pharmaceutical setting is essential.
• Thorough understanding of compliance regulations across the UK and Europe.

Responsibilities

• Lead and improve the Quality Management System.
• Maintain ISO certifications.
• Plan internal audits and supplier audits.
• Promote a culture of quality and compliance.

Skills

Quality Assurance

Regulatory Affairs

Leadership

Stakeholder Management

Problem-solving

Communication

Job description

Location: Manchester Airport

Salary: £50,000 - £55,000

Summary

We are seeking an experienced Quality Assurance & Regulatory Affairs (QARA) Manager to lead and maintain the Quality Management System and oversee regulatory compliance within a pharmaceutical distribution environment. This role is critical in ensuring that the business operates safely and in full compliance with UK and European standards.

Key Responsibilities

• Lead, maintain, and continuously improve the Quality Management System in line with relevant guidelines and legislation.
• Develop and manage both quality and health & safety frameworks in line with business growth and operational changes.
• Maintain ISO certifications (9001 / 14001) for the business.
• Plan and lead internal audits and supplier audits.
• Work closely with internal teams to align on quality and compliance.
• Promote a culture of quality, safety and compliance across the organisation.

Experience

• 5+ years' experience in Quality Assurance and Regulatory Affairs within supply chain operations.
• Previous experience in a pharmaceutical setting and knowledge of MDR (Medical Device Regulations) is essential for this role.
• Experience managing regulatory inspections and audits.
• Proven leadership and stakeholder management skills.
• Excellent documentation, communication, and problem-solving abilities.
• Thorough understanding of compliance regulations across the UK and Europe.
• Strategic mindset and able to take ownership and accountability for quality and safety within the business.

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All applicants must have an unrestricted right to work in the UK as our client will not support visa sponsorship for this role.