Global QMS & Projects Lead

BBI exists to help our customers create advances that improve health and save lives. We are seeking a Global QMS & Projects Lead to join our team. This is a permanent, full-time position based at our site in Crumlin. Join our team: advancing health, together.


The Role

The Global Quality Management Systems & Projects Lead is a key role on the Global Quality & Regulatory leadership team. The role is responsible for the design and implementation of the Global QMS, for driving the definition of global quality procedures, work instructions and processes and providing a consistent message about BBI’s Quality vision and plans. In addition, the role will identify, manage & drive efficiencies for continuous improvement of the electronic Quality Management System. The role is also responsible for the oversight and delivery of key Quality improvement projects whilst also contributing to BBI’s corporate audit program.


In this role your responsibilities will include:

• Responsible for designing and maintaining a Global eQMS in accordance with ISO 13485 Medical Device and Pharmaceutical cGMP guidelines
• Accountable for ensuring full quality and regulatory compliance needs of customers are incorporated into the Global BBI eQMS
• Responsible for preparing and executing a global education program for the use and application of the QMS
• Prepares and executes any specific Quality Management System audits.
• Works with sites to remediate QMS deficiencies
• Maintains positive agency relationships, liaisons with regulatory agencies and participates in external technical forums
• Participates in and drives the execution of BBI’s Quality Improvement projects
• Owns global compliance assessment and remediation plans while influencing site’s full execution.
• Influences Global policy and processes, development programs, communication packages and training requirements

Our Recruitment Process

If this role sounds like it’s for you, click ‘apply’ today. Once we’ve received your application, a member of our recruitment team will be in touch to arrange a call. On this call, we’ll be able to tell you a lot more about working here at BBI Solutions, how ‘a day in the life’ of this position looks and discuss the next stages of the recruitment process.

If you are an internal employee applying for this vacancy you and your manager are required to complete an internal transfer form. This needs to be completed in full and attached to your application along with your CV and cover letter.

As part of career development and succession planning internal applicants will receive priority consideration initially, please ensure that you apply within the initial two-week period to support this.


Why Choose BBI

We are committed to promoting and protecting the physical, financial, and emotional well-being of all our employees. With our employees focused on others, we’re focused on them. That’s why, at BBI, we’re dedicated to providing our employees with access to global resources and site-specific benefits that support their health and wellbeing.

• Competitive Salary with Yearly Salary Reviews
• 5% Contributory Pension Scheme
• Life Assurance (4x Annual Salary)
• Private Health Care Scheme – including dental
• Global Employee Wellbeing Programme
• Reward and Recognition Programme
• Commitment to Career Development
• Generous Annual Leave Package
• Cycle to Work Scheme
• Refer A Friend Scheme
• Subsidised Canteen
• Free Onsite Parking
• Electrical Vehicle Lease Scheme
• Electrical Charging Points
• State of the Art Facilities – Certified Centres of Excellence

We’re also focused on development, creating an environment that allows our employees to nurture their talent and empowers you to make a difference. This is achieved by providing our employees with access to learning opportunities to help achieve personal career goals.

About BBI

For more than 70 years, we’ve been perfecting reagents, both native and recombinant, to help IVD and life-science teams turn breakthrough ideas into reliable, life-saving advances.

Great products are only the start. From troubleshooting tricky performance issues and customising reagents to meeting new regulatory standards, our scientists work to clear obstacles and accelerate progress. That’s why we continue to invest millions in new recombinant capabilities that help create diagnostics that improve health and save lives - in a more ethical and sustainable way than ever before.


Equal Opportunities
BBI are an equal opportunity employer and believe in fair treatment for all candidates. Qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

We ask that all applicants complete an equal opportunity monitoring form on a voluntary basis, with all submissions remaining anonymous. The information on the form will be used for monitoring purposes only and will not be used in any decision affecting you.

Stay in Touch

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Please note that we reserve the right to close this advertisement at any time upon securing a suitable candidate.