Leidos are a growing company delivering innovative technology and solutions focused on safeguarding critical capabilities and transformation in frontline services, our work in the United Kingdom includes addressing some of the most complex problems in defence, healthcare, government, safety and security, and transportation.
Leidos Europe, part of Team Leidos, are looking for a Medicines and Healthcare Responsible Person to join their team in Bristol.
Team Leidos is honoured to support the UK MOD’s Logistic Commodities & Services Transformation (LCS[T]) programme, a critical effort to enhance and improve the UK’s defence supply chain.
The aim of this post is to provide a highly specialised level of Assurance, support and direction to professional and operational aspects of Good Distribution Practice (GDP) within Team Leidos within scope of the Wholesale Distribution Authorisation (WDA). This is in order to ensure the safe procurement, storage and distribution of medicinal products for human and animal use and protect end users against potential hazards arising from poor distribution practices within the WDA in a military setting in the United Kingdom and overseas, in peacetime and on Operations.
Quality risk management procedures and policies should ensure that the evaluation of risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient. The post holder will be eligible to be registered as a Responsible Person (RP) with the Medicines and Healthcare products Regulatory Agency (MHRA) and will lead on policy and procedure development and implementation from GDP (UK and EU) regulations and legislation and GDP related audit. This work will inform and shape the overall Team Leidos pharmaceuticals procurement & Distribution strategy, which will assist and support Defence by providing the overarching framework to enable a safe and effective supply chain for Medicinal products.
Knowledge, skills & experience
Eligible to be registered as a Responsible Person (RP) with the Medicines and Healthcare products Regulatory Agency (MHRA) for Human & Veterinary WDA.
Eligible to be named on a Home Office Controlled Drugs License.
Experience of the Military Supply Chain
Detailed knowledge of current GDP Guidance/Legislation and some knowledge of current GMP requirements.
Must be able to obtain a UK Security Check clearance.
Registered Pharmacist or Pharmacy Technician
Post-Graduate qualification in a subject related to Pharmacy, Procurement/Logistics, Quality or Project Management.
General knowledge and experience of primary, community and secondary healthcare.
In-depth knowledge of the legislation, regulations and guidance associated with the safe and effective procurement, distribution and storage of pharmaceuticals.
Relevant experience of working & influencing at senior strategic level.
Experience of dealing with highly complex and specialised Pharmacy related issues requiring analysis of information from a variety of sources.
Experience of conducting GDP Audits
Experience of Implementing and assuring Quality Management Systems
Organisational skills with ability to manage multiple strands of work.
Experience of facilitating change.
IT literate in order to extract and present information from variety of sources.
Able to travel to UK based locations
The RP is responsible for safeguarding product users against potential hazards arising from poor distribution practices. The duties of a RP include:
Ensure that the provisions of the licences are observed and maintained including the monitoring, review and implementation of new and emerging legislation. The RP will be the prime point of contact for the MHRA, Home Office and other European Regulators as applicable.
Ensure that the operations do not compromise the quality of medicines by ensuring that a robust and workable Quality Management System is in place and maintained to meet regulatory and customer requirements. To work closely with teams and functions to support incidents and take a proactive approach to providing effective solutions
Oversee audit of the quality system and to carry out independent audits including the implementation and schedule adherence of a self-inspection programme.
Ensure that adequate records are maintained
Vendor evaluation and qualification of suppliers of Pharmaceutical products and 3PL providers.
Ensure that all personnel are trained and aware of GDP requirements.
Ensure full and prompt cooperation with product licence holders in the event of recalls.
Responsible for the management and performance of the QMS, including strategic policy setting, continuous improvement, quality management reviews, risk management, change control, complaints, Deviation management, investigation and CAPA, self-inspection and generation of technical/quality agreements.
The Leidos Europe Ltd RP will lead, manage and develop the RP’s and deputy RP’s across Team Leidos and continually review ways of working to improve processes and procedures to deliver a GDP compliant Supply Chain across the business.
What do we do for you?
We offer meaningful and engaging careers, a collaborative culture, and support for your career goals, all while nurturing a healthy work-life balance.
We provide an employment package that attracts, develops and retains only the best in talent.
Our reward scheme includes:
- Contributory Pension Scheme
- 33 days Annual Leave (including public and privilege holidays)
- Access to Flexible benefits (including life assurance, health schemes, and cycle to work scheme)
External Referral Bonus:Ineligible
Potential for Telework:No
Clearance Level Required:Other Clearance
Travel:Yes, 10% of the time
Scheduled Weekly Hours:40
Job Family:Testing and Quality Assurance
Leidos is a Fortune 500® information technology, engineering, and science solutions and services leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 38,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Va., Leidos reported annual revenues of approximately $11.09 billion for the fiscal year ended January 3, 2020. For more information, visit www.Leidos.com.
Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here.
Leidos will never ask you to provide payment-related information at any part of the employment application process. And Leidos will communicate with you only through emails that are sent from a Leidos.com email address. If you receive an email purporting to be from Leidos that asks for payment-related information or any other personal information, please report the email to [email protected].
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.