Quality Manager - Responsible Person

Smart4 Sciences - specialists in pharmaceutical recruitment - are currently supporting a highly compliant and quality-driven pharmaceutical organisation in London in their search for a Quality Manager / Responsible Person (RP).

This is a key hire within a regulated WDA/MIA/MAH environment, offering the opportunity to take ownership of the Pharmaceutical Quality Management System and act as a primary liaison with the Medicines and Healthcare products Regulatory Agency and EU authorities.

The Opportunity

This position sits at the heart of regulatory and operational compliance. You will play a critical role in maintaining and continuously improving the Pharmaceutical Quality System while ensuring full adherence to UK and EU regulatory frameworks.

The organisation operates within a highly regulated wholesale and authorisation landscape and requires a confident QA professional who thrives in inspection-led environments.

Key Responsibilities

• Lead, maintain and enhance the Pharmaceutical Quality Management System (QMS)
• Oversee compliance across:
• Wholesale Distribution Authorisation (WDA)
• Manufacturer's/Importer's Authorisation (MIA)
• Marketing Authorisation Holder (MAH) activities
• Ensure full compliance with UK & EU GMP and GDP requirements
• Act as primary contact for the Medicines and Healthcare products Regulatory Agency and EU regulatory bodies
• Lead regulatory inspections, manage responses and drive CAPA implementation
• Oversee deviations, change controls, complaints, recalls, supplier qualification and self-inspections
• Support regulatory strategy and business continuity initiatives

What We're Looking For

• Significant QA experience within a WDA, MIA or MAH pharmaceutical environment
• Strong working knowledge of UK & EU GMP and GDP regulations
• Proven experience hosting and managing regulatory inspections
• Direct liaison experience with the Medicines and Healthcare products Regulatory Agency and/or EU competent authorities
• In-depth understanding of pharmaceutical QMS lifecycle processes
• Strong knowledge of UK Human Medicines Regulations and EU pharmaceutical directives

Qualifications

• Degree in Pharmaceutical Sciences, Chemistry, Life Sciences or related discipline
• Eligibility to act as Responsible Person (RP) under WDA (highly desirable)
• GMP/GDP auditing or Quality Management certifications advantageous

Why Apply?

This is an excellent opportunity for a senior QA professional ready to step into a highly influential compliance role within a growing pharmaceutical business. The position offers strong visibility, regulatory ownership, and the opportunity to shape quality strategy in a dynamic wholesale environment.

If you are an experienced QA professional or RP open to a confidential discussion, contact Gareth Sciences today to learn more.