The Opportunity
QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.
Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.
IT Business Relationship Lead – Quality Systems
As QuidelOrtho continues to grow, we are looking to hire an IT Business Relationship Lead to collaborate with QuidelOrtho’s Quality Systems team helping to build and maintain solutions supporting the company’s Quality Assurance and Quality Compliance organization, centered on the company Windchill PLM and OpenText systems. This role will be based in Pencoed, on a hybrid basis.
About QuidelOrtho, Pencoed
QuidelOrtho has been manufacturing products in South Wales for over 40 years. Our state-of-the-art manufacturing facility, based in Pencoed, employs over 600 people who are involved in the manufacture and supply of clinical laboratory and immunohematology products to sites across the globe.
Our Pencoed team manufacture a large menu of immunohematology products used in transfusion medicine; in addition to a large menu of immunoassay products encompassing a range of disease categories.
On site we have a range of functions operating globally & locally. All our employees are working towards one common goal, to help save and improve lives through diagnostics.
Your new role:
As the IT Business Relationship Lead you will collaborate with QuidelOrtho’s Quality Systems team helping to build and maintain solutions supporting the company’s Quality Assurance and Quality Compliance organization, centered on the company Windchill PLM and OpenText systems.
This is a hands-on position that delivers thought leadership and project management leadership on large initiatives. The successful candidate will be a key influencer in helping to implement a modern system frame work enabling efficiency and support of Ortho’s Quality processes and assuring compliance with global regulatory organizations.
The position will focus initially on three primary dimensions: (1) the modernization of a traditional quality systems to a PLM systems framework approach in alignment with company strategy; (2) ensure that solutions are deployed and maintain successful across the entire company enterprise. (3) The modernization of strategies around quality assurance systems, that combine multiple aspects of connected devices (IoT), outputs from the manufacture of products, to allow the reliable use of Ortho products in customer laboratories.
This position will be the primary liaison point between the business and IT for quality and quality assurance systems.
What you’ll be doing:
- Ensure that QuidelOrtho’s IT organization has a thorough understanding of Business Requirements from the Quality Assurance and Quality Compliance organization.
- Partner with Quality Systems teams to propose global solutions that enhance efficiency, compliance and traceability and build best in industry capability for QuidelOrtho.
- Monitor the effectiveness of existing and new solutions and the business performance of those solutions.
- Become a subject matter expert in quality systems. Become an expert in business processes, and work with the business to help define and document, requirements to support deployment of new systems as well as enhancements to existing systems.
- Work closely with the business assisting in the authoring and approval of systems documentation (user documentation, requirments, testing, risk, and traceability) . Lead and participate in the design, configuration and testing of projects related to Quality Systems.
- Primary liaison with business for the support or existing applications and development of new applications.
- Follow standard GIS prioritization and change management processes.
- Follow System Development Lifecycle (SDLC) process to design, develop and test complex solutions.
What you’ll need to succeed:
- Demonstrable work experience in the following areas:
- Quality Systems
- PLM Systems
- Quality Assurance
- Quality Compliance
- Work history operating in a Medical Device or Pharmaceutical organization highly advantageous.
- Audit experience in respect of software validation desirable.
- Strong verbal and written communication skills.
- Excellent analytical and problem-solving skills.
- Technical or working experience with Windchill PLM highly desirable.
- Technical or working experience with Technical or working experience established PLM or quality systems platforms advantageous.
- Computer skills: Proficiency with Microsoft Office (Excel, PowerPoint and Word),
- Proven project management track record in delivering global projects from inception thought to completion. Develop, execute and adjust a plan with high degree of independence.
- Experience partnering with a matrix teamed of professionals; and communicating with various levels of management is highly desired. Ability to work with all levels of the organization, both technical and non-technical.
- Proactive, self-motivated with the ability to motivate others and a customer-focused attitude.
- Strong prioritization skills to achieve long-term and short-term results.
- Ability to build and maintain strong relationships throughout the organization and collaborate with other departments and teams.
- Ability to determine customer-specific needs and put forth actions to meet those needs.
What we offer:
- Competitive Salary
- Yearly Salary Reviews
- Attractive Pension Scheme
- Bonus Scheme
- Life Assurance
- Private Medical (If applicable)
- LinkedIn Learning
- Cycle to Work Scheme
- Free Onsite Gym
- Subsidised Canteen
- 25 days Holidays + 8 Bank Holidays (Milestone Increases Available)
- Employee Assistance Programme
- Reward & Recognition Programmes
- State-Of-The-Art facilities
- Exceptional career developmental prospects
- Strong culture centred around collaboration & customer focus.
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What We Do
Ortho Clinical Diagnostics (Nasdaq: OCDX) is one of the world’s largest pure-play in vitro diagnostics (IVD) companies dedicated to transforming patient care. More than 800,000 patients across the world are impacted by Ortho’s tests each day. Because Every Test is a Life, Ortho provides hospitals, hospital networks, clinical laboratories and blood banks around the world with innovative technology and tools to ensure test results are fast, accurate, and reliable. Ortho's customized solutions enhance clinical outcomes, improve efficiency, overcome lab staffing challenges and reduce costs. From launching the first product to determine Rh+ or Rh- blood type, developing the world’s first tests for the detection of antibodies against HIV and hepatitis C, introducing patented dry-slide technology and marketing the first U.S. Food and Drug Administration-authorized high-volume antibody and antigen tests for COVID-19, Ortho has been a pioneering leader in the IVD space for over 80 years. The company is powered by Ortho Care, an award-winning, holistic service and support program that ensures best-in-class technical, field and remote service and inventory support to laboratories in more than 130 countries and territories around the globe.
