Join our team and play a pivotal role in ensuring the highest quality standards within the UK healthcare network. Drive continuous improvement and compliance while making a real impact on the distribution of medicines.

YOUR SKILLS AND EXPERIENCES

• Quality Assurance Experience: Proven experience in a quality assurance role within the pharmaceutical industry or pharmaceutical distribution industry, including an understanding of the associated supply chain requirements.
• RP Training: Successful completion of an (MHRA) Responsible Person (RP) course.
• GDP Knowledge: Extensive knowledge of the principles and guidelines of Good Distribution Practice (GDP) and related legislation and industry best practise, this role requires a high level of technical expertise.
• Legislation: Comprehensive understanding of the Falsified Medicines Directive and related transport and distribution legislation within the pharmaceutical and healthcare sectors.
• Controlled Substances Compliance: In-depth knowledge of compliance requirements for the transport and storage of Controlled Substances, including adherence to Home Office Guidance.
• Quality Processes and ISO9001: Familiarity with quality processes, requirements, and formats, as well as compliance with ISO9001 standards.
• Policy and Procedure Development: Experience in drafting clear and concise policies and procedures.
• Responsible Person Designation: Current or previous designation as a Responsible Person on a license.
• Training Expertise: Ability to design and conduct training events, with relevant training experience.
• Regulatory Interaction: Experience in dealing with regulators and applying for licenses for the storage of pharmaceutical and medicinal products (e.g., WDA (H+V) and Controlled Drugs Licenses).
• GMP and Medical Devices: Experience with compliance and quality for medical devices andGood Manufacturing Practices (GMP) is advantageous but not essential.
  

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YOUR ROLE

We are looking for a National Healthcare Compliance Manager to ensure compliance with Good Distribution Practice (GDP) and safeguard the quality of medicines within our UK healthcare network. You will oversee licenses, authorizations, and certifications, while maintaining adherence to EU Directives, MHRA guidelines, and relevant regulations. In addition, you will manage the Quality Management System (QMS), drive continuous improvements, and support sales and customer teams to align with GDP requirements. This role offers the opportunity to contribute to risk management, process design, and operational efficiency in a dynamic and impactful environment.

YOUR RESPONSIBILITIES

• Improvement: Foster a culture of continuous improvement and unwavering quality within the UK healthcare network
• Fulfil the duties of the Responsible Person (RP) in accordance with Good Distribution Practice (GDP) guidelines, ensuring all licenses and authorizations are maintained. The primary objective is to ensure that operations do not compromise the quality of medicines and to continuously improve quality.
• Compliance and Implementation: Ensure adherence to EU Directives, Regulations, MHRA Guidelines on GDP, and any associated customer and legislative requirements related to the Healthcare vertical, across all business units.
• Focal Point for Compliance: Serve as the central point of contact for compliance-related matters within the organization.
• Sales and Customer Support: Provide support to our customers, our sales and customer service teams to ensure alignment with GDP requirements.
• Licenses and Authorizations: Maintain all necessary licenses and authorizations to legally distribute medicines and any associated certifications.
• Quality Assurance: Safeguard the quality of medicines throughout the distribution process.
• Compliance: Ensure compliance with licensed/authorized activities and the accuracy and quality of associated processes.
• Ensure the Quality Management System (QMS) is documented, implemented, and maintained to meet the requirements of Good Distribution Practice (GDP), ISO9001, CEIV Pharma, associated healthcare regulatory requirements, and KN standards.
• Risk Management: A risk management approach should be applied to identify, assess, and mitigate risks associated with the distribution of healthcare products.