QARA Manager: Pharma Quality & Regulatory Lead

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

Job summary

A specialized healthcare services provider is seeking an experienced Quality Assurance & Regulatory Affairs Manager to lead quality management efforts and regulatory compliance. The successful candidate will enhance the Quality Management System, ensure compliance with UK and EU standards, and manage audits and inspections. Ideal candidates will have over 5 years of experience in regulatory affairs within the pharmaceutical sector and a thorough understanding of ISO standards and Medical Device Regulations. This position is based in Manchester.

Qualifications

• 5+ years of experience in Quality Assurance within supply chain operations.
• Experience managing regulatory inspections and audits.
• Knowledge of Medical Device Regulations (MDR) is essential.

Responsibilities

• Lead and improve the Quality Management System according to guidelines.
• Develop health and safety frameworks aligned with business growth.
• Maintain ISO certifications (9001 / 14001) for the organization.
• Plan and conduct internal and supplier audits.
• Align with internal teams on quality and compliance.
• Promote a culture of quality and safety within the organization.

Skills

Quality Assurance

Regulatory Affairs

Internal Audits

SOP Development

ISO 9001/14001

Job description

A specialized healthcare services provider is seeking an experienced Quality Assurance & Regulatory Affairs Manager to lead quality management efforts and regulatory compliance. The successful candidate will enhance the Quality Management System, ensure compliance with UK and EU standards, and manage audits and inspections. Ideal candidates will have over 5 years of experience in regulatory affairs within the pharmaceutical sector and a thorough understanding of ISO standards and Medical Device Regulations. This position is based in Manchester.