Quality Assurance Associate

Reports to: Head of Quality Assurance
Department: Quality Assurance

What We Do

At Qmed, our vision is to lead the global pharmaceutical industry as the most ethical and client-focused provider of products and services. We aim to make pharmaceutical services simple, reliable, and ethical by supporting healthcare providers and partners with end-to-end supply chain solutions.

Qmed specializes in the sourcing and supply of over-labelled medicines and imported unlicensed medicines to NHS hospitals, private healthcare providers, and pharmacies throughout the UK. Through our regulatory expertise, global sourcing network, and customer-focused approach, we help ensure continuity of supply for essential medicines when licensed alternatives are unavailable or in short supply.

Why Join Qmed

Our success is driven by our people. We are a collaborative, high-performing organization where people are supported to grow and contribute meaningfully. This role offers the opportunity to play a key part in a fast-growing area of the business, supporting healthcare providers with access to essential medicines during supply disruption.

This role provides an exciting opportunity for a quality professional to gain further exposure to quality processes while using existing skills to support ongoing compliance, maintain effectiveness, and help continually improve our quality management system. The role holder will be able to make a real impact to a developing quality management system and the culture of quality at Qmed.

Job Purpose / About the Role

The Role holder will ensure that all manufacturing and distribution operations strictly comply with business and regulatory requirements (MHRA and Home Office for Controlled Drugs) to guarantee product and patient safety. Act as the frontline defense against deviations and regulatory non-compliance before a product is released and distributed to the public.

The Quality Assurance Associate supports the maintenance and continuous improvement of the pharmaceutical quality system within a growing pharmaceutical business. The role helps ensure that medicinal products are procured, received, stored, handled, processed, transported, returned, and supplied in compliance with applicable GDP and GMP requirements, company procedures, regulatory expectations, and product license conditions. As the business expands, the post holder will also contribute to scalable quality processes, operational readiness, supplier and customer growth, and the development of a mature quality culture.

The role reports to the Head of Quality Assurance. The post holder works closely with distribution operations and warehouse teams, production department, transport providers, customer service, regulatory affairs, and approved third-party service providers to ensure GDP and GMP compliance throughout the supply chain.

This role is suitable for an individual who can grow with the business and develop into a more senior quality position. With appropriate experience, training, and demonstrated competence, the post holder may progress towards wider ownership of GDP and/or GMP quality systems, supplier and customer qualification, internal audit programs, quality metrics, management review input, inspection readiness, team mentoring, or deputy support to the Responsible Person.

Working closely with the Head of Quality, you will be responsible for developing and enhancing existing quality management systems and implementing continuous improvement initiatives to ensure ongoing compliance to manage the WDA, MIA, and MS licenses.

A key objective of this role is to ensure that Qmed is in a continuous state of inspection readiness.

Key Responsibilities:

• Lead the generation and update of quality documentation and agreements
• Manage the implementation, maintenance, and improvement of the quality management system, including SOPs, work instructions, forms, and quality records.
• Review and manage GDP and GMP documentation to ensure records are accurate, complete, attributable, legible, contemporaneous, original, and readily retrievable.
• Lead on deviation, incident, non-conformance, and temperature excursion investigations, including root cause analysis and corrective and preventive action tracking.
• Manage change control activities affecting storage, distribution, transportation, suppliers, customers, systems, facilities, and outsourced service providers.
• Lead in the qualification, approval, and periodic review of suppliers, customers, transport providers, warehouses, and other GDP and GMP-relevant third parties.
• Monitor storage and transport conditions, including review of temperature monitoring data, calibration records, alarms, and environmental-control documentation.
• Manage complaints, returns, suspected falsified medicines, recalls, and product withdrawal processes in accordance with approved procedures and regulatory timelines.
• Plan and conduct self-inspections, internal audits, supplier audits, and regulatory inspection preparation, including follow-up of observations and CAPA closure.
• Maintain GDP and GMP training records and manage role-specific training, refresher training, and awareness activities for personnel involved in distribution operations.
• Promote a quality culture by escalating risks, supporting continuous improvement, and ensuring GDP and GMP requirements are understood and followed across relevant teams.
• Actively participate in the design and implementation of scalable GDP and GMP quality processes that can grow with increased product volumes, customer demand, supplier networks, and distribution complexity.
• Identify opportunities to improve quality systems, reduce manual administration, strengthen compliance controls, and increase process efficiency while maintaining patient safety and product integrity.
• Contribute to readiness planning for business growth, including new warehouse activities, new customers, new transport arrangements, additional suppliers, expanded product ranges, or changes to operating models.
• Lead in developing quality metrics, trend reports, risk assessments, and management review inputs to support informed decision-making by senior management.
• Manage cross-functional projects that affect GDP and GMP compliance, including system implementation, process mapping, outsourcing decisions, facility changes, and operational improvement initiatives.
• Help embed a proactive quality culture by coaching colleagues, sharing GDP and GMP expectations, escalating emerging risks, and encouraging ownership of quality across operational teams.
• Provide guidance and support to Junior QA personnel and colleagues on GDP and GMP quality system requirements.