QA/ RA PROJECT MANAGER (12 MONTH FTC)
Would you like to be part of an organisation which is committed to improving patient lives worldwide through education, collaboration and innovation?
Do you want to make a difference?
If the answer is ‘yes’ then you’re just the kind of person we’re looking for!
We have a fantastic opportunity working in our busy Quality Assurance department for a QA/RA Project Manager. This role will be responsible for supporting business wide projects across multiple departments at the Binding Site.
The successful candidate, will manage to completion the delivery of projects for The Binding Site which have significant Quality Assurance and Regulatory impact on requirements. These projects will have a direct impact on business elements such as compliance, cost saving and process efficiency. You are required to ensure that companywide projects meet all requirements of relevant regulatory standards and Regulations: (ISO13485, FDA 21CFR part 820 and the IVDR).
Essential requirements
- A levels or equivalent in Science
- Working knowledge of FDA part 820, ISO13485, cGMP, IVDR
- Experience of working within RA/QA environment within an IVD or medical device company
- Working in a Quality Assurance Manager/Manager Level/Supervisor level – to ensure compliance
- Knowledge of the application of quality systems in manufacturing.
- Knowledge of New Product Development
- Excellent communication skills both written and verbal
- To have a good understanding of Quality principles/Quality systems and regulations for IVD/medical device company
- To be flexible to the need of the business
- To have a work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgement, decision making and ambition.
- Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment.
Working for us:
Founded in 1986 by a group of former researchers based at the University of Birmingham, The Binding Site is today recognised as a market leader in the development of products for the investigation of a range of disorders involving immunodeficiency.
The Company is built on the success of its people and provides the ideal environment to meet a wide range of career aspirations. It recognises the value of its employees and looks to provide development and support opportunities to maximise the potential of its 1,100 staff.
Working at Binding Site means being part of a global community that delivers innovative solutions with shared ideas and a collective dedication to improving patient lives, worldwide.
Location: Birmingham
Hours: 40 hrs (Hybrid home working & Birmingham office)
Benefits:
- Competitive Salary
- Contributory Pension
- 25 days paid holiday plus bank holidays
- Life Assurance
- Medicash Health Benefit.