National Pharma and Healthcare Compliance Manager | United Kingdom | JR2501_0019
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 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 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. 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. Serve as the central point of contact for compliance-related matters within the organization. Provide support to our customers, sales, and customer service teams to ensure alignment with GDP requirements. Maintain all necessary licenses and authorizations to legally distribute medicines and any associated certifications. Safeguard the quality of medicines throughout the distribution process. 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. Apply a risk management approach to identify, assess, and mitigate risks associated with the distribution of healthcare products.
YOUR SKILLS AND EXPERIENCES Proven experience in a quality assurance role within the pharmaceutical industry or pharmaceutical distribution industry, including an understanding of the associated supply chain requirements. Successful completion of an (MHRA) Responsible Person (RP) course. Extensive knowledge of the principles and guidelines of Good Distribution Practice (GDP) and related legislation and industry best practice. Comprehensive understanding of the Falsified Medicines Directive and related transport and distribution legislation within the pharmaceutical and healthcare sectors. In-depth knowledge of compliance requirements for the transport and storage of Controlled Substances, including adherence to Home Office Guidance. Familiarity with quality processes, requirements, and formats, as well as compliance with ISO9001 standards. Experience in drafting clear and concise policies and procedures. Current or previous designation as a Responsible Person on a license. Ability to design and conduct training events, with relevant training experience. 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). Experience with compliance and quality for medical devices and Good Manufacturing Practices (GMP) is advantageous but not essential.
GOOD REASON TO JOIN If you would like to become a valued member of our team, we will make sure that you're rewarded for your commitment and expertise. You can join the contributory Kuehne+Nagel pension plan and enjoy our Route 2 Rewards scheme, which offers everything from discounts, benefit information, recognition and its own wellbeing centre. We care for our colleagues (and their immediate family) with our employee assistance programme providing access to 24/7 GP, legal and financial advice along with mental health counselling. All of this to help you live a happier and healthier life. As proud holders of the Gold Covenant, we are a forces-friendly employer who recognise the skills, expertise and value service leavers bring to our organisation.
ABOUT KUEHNE+NAGEL With over 80,000 employees at some 1,300 locations in over 100 countries, the Kuehne+Nagel Group is one of the world's leading logistics companies.
CONTACT Dijana Mihic +49 (0)304036371605
#J-18808-Ljbffr
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 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 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. 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. Serve as the central point of contact for compliance-related matters within the organization. Provide support to our customers, sales, and customer service teams to ensure alignment with GDP requirements. Maintain all necessary licenses and authorizations to legally distribute medicines and any associated certifications. Safeguard the quality of medicines throughout the distribution process. 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. Apply a risk management approach to identify, assess, and mitigate risks associated with the distribution of healthcare products.
YOUR SKILLS AND EXPERIENCES Proven experience in a quality assurance role within the pharmaceutical industry or pharmaceutical distribution industry, including an understanding of the associated supply chain requirements. Successful completion of an (MHRA) Responsible Person (RP) course. Extensive knowledge of the principles and guidelines of Good Distribution Practice (GDP) and related legislation and industry best practice. Comprehensive understanding of the Falsified Medicines Directive and related transport and distribution legislation within the pharmaceutical and healthcare sectors. In-depth knowledge of compliance requirements for the transport and storage of Controlled Substances, including adherence to Home Office Guidance. Familiarity with quality processes, requirements, and formats, as well as compliance with ISO9001 standards. Experience in drafting clear and concise policies and procedures. Current or previous designation as a Responsible Person on a license. Ability to design and conduct training events, with relevant training experience. 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). Experience with compliance and quality for medical devices and Good Manufacturing Practices (GMP) is advantageous but not essential.
GOOD REASON TO JOIN If you would like to become a valued member of our team, we will make sure that you're rewarded for your commitment and expertise. You can join the contributory Kuehne+Nagel pension plan and enjoy our Route 2 Rewards scheme, which offers everything from discounts, benefit information, recognition and its own wellbeing centre. We care for our colleagues (and their immediate family) with our employee assistance programme providing access to 24/7 GP, legal and financial advice along with mental health counselling. All of this to help you live a happier and healthier life. As proud holders of the Gold Covenant, we are a forces-friendly employer who recognise the skills, expertise and value service leavers bring to our organisation.
ABOUT KUEHNE+NAGEL With over 80,000 employees at some 1,300 locations in over 100 countries, the Kuehne+Nagel Group is one of the world's leading logistics companies.
CONTACT Dijana Mihic +49 (0)304036371605
#J-18808-Ljbffr
