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 Gooley @ Smart4 Sciences today to learn more