European Quality/Regulatory Affairs Manager
Salary very competitive (negotiable depending on experience) + Benefits
LiCa Scientific are working exclusively with the client in Bristol as their recruitment partner for a European Quality/Regulatory Affairs Manager.
We are hiring for a Quality Assurance/Regulatory Affairs Manager for our client based in Bristol to join their Quality team. They are a trusted manufacturer/supplier of innovative and high-performance life science reagents and have been working with scientists for over 30 years to provide the life science community with the latest research tools available. They are part of a multi-national company with a global footprint. The company is currently moving into a more diverse market and as such this is an exciting time to get on board.
This position is responsible for managing and directing Quality Assurance and RA activities for the client and will provide quality/regulatory guidance throughout the EMEA organization. Responsibilities include, but are not limited to, preparing documentation relating to the GMP product range, managing the Bristol site Quality Management System and serving as primary contact for quality/regulatory issues related to assigned products.
The main site for the client is based in Bristol however there is potential for this role to be based out of the Abingdon office if more suitable for the successful candidate. Some European travel will also be involved to support the additional offices in their Quality/Regulatory needs.
Key responsibilities for the Quality Assurance/Regulatory Affairs Manager role:
What you’ll do:
- Participate in team meetings as Quality/Regulatory lead and serve as primary contact for quality/regulatory issues.
- Implementation of quality objectives and plans to maintain the Quality Management Systems throughout the organization.
- Provide quality/regulatory guidance in the qualification and operation of the controlled GMP manufacturing area.
- File appropriate documentation with regulatory agencies for the products, including license applications and annual returns.
- Respond to customer and supplier quality / regulatory requests regarding products.
- Participate in external audits conducted by regulatory authorities and customers and conduct supplier audits.
- Work collaboratively with all functions to ensure conformance with all quality and regulatory requirements.
- Provide leadership throughout the organization to ensure compliance with internal and external quality requirements through policy and procedure development and implementation.
- Lead relevant internal training courses.
- Lead vendor qualification.
- Perform additional duties as assigned.
For the European Quality/Regulatory Affairs Manager role:
- Ideally qualified to degree level with a minimum of five years working in a QA/RA environment.
- An excellent understanding of the product portfolio.
- Expert knowledge of Quality Management Systems, including GMP, ISO 9001 and ISO 13485.
- Knowledge of regulatory requirements in global markets, including US and EU.
- Excellent verbal and written communication skills including technical writing skills.
- Excellent attention to detail, time management, project management and organizational skills.
- Excellent ‘can do’ attitude.
- Ability to perform a wide variety of tasks and multi-task efficiently.
- Ability to remain calm under pressure and work to deadlines.
- Ability to build strong relationships cross functionally.
- Ability to make effective decisions and execute an appropriate course of action which complies with quality and regulatory requirements while supporting business objectives.
- Ability to handle sensitive and proprietary information with discretion and confidentiality.
Salary range for the European Quality/Regulatory Affairs Manager role is highly competitive and will be commensurate with skills and experience of successful candidate and comes with a competitive benefits package including pension and healthcare/dental.
To apply for the European Quality/Regulatory Affairs Manager role:
Please direct your application to this advert as all applications are via LiCa Scientific.
Cover notes supporting your application are welcomed. On this occasion LiCa Scientific is acting as an employment agency.
Please email firstname.lastname@example.org with your most up to date CV and a cover letter.
Should you be keen to have an informal conversation ahead of application please email email@example.com and we’ll be happy to set this up.