Leidos Europe Ltd is seeking a UK-based Medical Supplier Quality Manager who is a motivated self-starter who can work independently and as part of a team in a dynamic environment. They will be a dedicated resource to the Logistics Division working on the Ministry of Defence Logistics, Commodities and Services Transformation (LCST) Programme.
Reporting to the Leidos Europe Responsible Person (RP) the role is responsible for safeguarding product users against potential hazards arising from poor distribution practices, acting as a key contact for associated issues.
You will be a key member of the compliance team, and have a real tangible as well as strategic input within a growing business. You will be accountable for driving the culture of quality and compliance to the next level as the programme continues to expand.
The role will be home-based with some travel required.
Duties & Responsibilities:
The Medical Supplier Quality Manager is responsible for safeguarding product users against potential hazards arising from poor procurement, distribution and manufacturing practices. The duties include:
Supporting the RP to ensure that the provisions of the licences are observed and maintained; including the monitoring, review and implementation of new and emerging legislation.
Updating the existing QMS to deliver compliance with ISO 13485, relevant standards & regulations as they are updated or superseded and to match developments in best practice.
Act as a key contact for the MHRA, Home Office and other European Regulators as applicable.
To work closely with teams and functions to support incidents and take a proactive approach to providing effective solutions.
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.
Support training and awareness of GDP/GMP requirements.
Support prompt cooperation with product licence holders in the event of recalls.
Responsible for the management and performance of the QMS, including 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 Medical Supplier Quality Manager will continually review ways of working to improve processes and procedures to deliver a GDP compliant Supply Chain across the business.
An experienced GDP Quality Manager with a strong quality background currently working within industry.
ISO13485 Lead Auditor Qualification
A degree in a relevant scientific discipline would be advantageous, as would a number of years working within an established quality team in a pharmaceutical organisation.
Proven experience working as an auditor and development, implementation and maintenance of quality systems is essential.
Willingness to achieve SC clearance
Willing to travel
Desirable Skills Required:
Experience working with the following tools: SharePoint, MS Office products (Word, Excel, PowerPoint), Jira
Active SC security clearance
Experience of developing and implementing processes
Implementing corrective and preventative actions (CAPA)
Experience of Internal, external and supplier auditing
What we do for you:
At Leidos we are PASSIONATE about customer success, UNITED as a team and INSPIRED to make a difference. 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
Private Medical Insurance
33 days Annual Leave (including public and privilege holidays)
Access to Flexible benefits (including life assurance, health schemes, gym memberships, annual buy and sell holidays and a cycle to work scheme)
Commitment to Diversity:
We welcome applications from every part of the community and are committed to a truly diverse and inclusive culture. We foster a sense of belonging, welcoming all perspectives and contributions, and providing equal access to opportunities and resources for everyone. If you have a disability or need any reasonable adjustments during the application and selection stages please let us know, and we will respond in a way that best fits your needs.
Who we are:
Leidos UK & EUROPE – we work to make the world safer, healthier, and more efficient through technology, engineering and science.
Leidos is 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.
The Logistics Commodities & Services Transformation (LCST) Programme for the UK Ministry of Defence is a critical effort to enhance and improve the UK’s defence supply chain. The programme provides essential services such as storage and distribution for the MOD's materiel, including a global freight service and the procurement and inventory management of 70,000 commodity NATO Stock Number (NSNs).
Working together as Team Leidos we are helping to transform the UK's defence supply chain by providing an integration of a complex mixture of services, at low risk, using a modern suite of systems that will deliver one version of the truth. For the first time, the MOD will see the whole picture, as it is happening.
What Makes Us Different:
Purpose: you can use your passion and abilities at Leidos to keep the people you care about safe. We are at the forefront of machine learning, AI, cyber security and solutions. Using your skills in the technology frontline by helping to build a safer world. You can inspire change.
Collaboration: having flexibility to do your job is one of our core benefits, enabling you to become part of our extraordinary team. We have been empowering our people to work flexibly for years. Whether you work from home, the office or on customer sites, we will give you the digital tools and the flexibility to work smarter and align your needs and ours.
People: Leidos empowers people from every background to be themselves and gives you the tools to learn new skills by enabling growth whilst developing. We believe that extraordinary people need opportunities to grow, to be inspired and to inspire others. At Leidos, we invest in technical academies, career rotations and a career development plans that enhance your future.
The Leidos pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
Leidos is a Fortune 500® technology, engineering, and science solutions and services leader working to solve the world’s toughest challenges in the defense, intelligence, civil, and health markets. The company’s 45,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported annual revenues of approximately $14.4 billion for the fiscal year ended December 30, 2022. For more information, visit www.Leidos.com.
Pay and Benefits
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.
Securing Your Data
Beware of fake employment opportunities using Leidos’ name. Leidos will never ask you to provide payment-related information during any part of the employment application process (i.e., ask you for money), nor will Leidos ever advance money as part of the hiring process (i.e., send you a check or money order before doing any work). Further, Leidos will only communicate with you through emails that are generated by the Leidos.com automated system – never from free commercial services (e.g., Gmail, Yahoo, Hotmail) or via WhatsApp, Telegram, etc. If you received an email purporting to be from Leidos that asks for payment-related information or any other personal information (e.g., about you or your previous employer), and you are concerned about its legitimacy, please make us aware immediately by emailing us at [email protected].
If you believe you are the victim of a scam, contact your local law enforcement and report the incident to the U.S. Federal Trade Commission.
Commitment to Diversity
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.