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Senior GCP Quality Expert

Employer
Albion Rye Associates
Location
Near Zurich
Salary
Highly competitive + benefits
Start date
3 Nov 2023
Closing date
3 Dec 2023

View more

Discipline
Quality, GCP
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Role: Senior GCP Quality Expert

Location: Zurich, Switzerland

 

Albion Rye Associates are pleased to be working in partnership with a clinical-stage biopharmaceutical company focussed on revolutionising patient outcomes with their targeted approach to developing solutions within the field of immunology.

 

Playing a key role within the Global Quality Team, the successful Senior GCP Quality Expert will work closely with senior management to ensure that all quality processes and quality management systems are maintained and monitored closely as per company standards. In addition, the Senior GCP Quality Expert will work closely with the Clinical Development team to advise on all quality related GCP activities.

 

This is a fantastic opportunity to join a pioneering organisation during a key stage in their company development, offering a fast-paced working environment and chance to take ownership within the quality function from day one.

 

Main responsibilities (to include but not be limited to):

  • Takes ownership of maintaining and monitoring the GxP Quality Management System (QMS), ensuring that the QMS meets all necessary regulatory requirements, with a specific emphasis on GCP compliance. Provides support and advice to the business with regards to the development and definition of GxP compliance procedures, management of quality issues, and monitoring of external contracted organisations and service providers. Responsible for the definition of and management of the GCP audit programme Ensures that all quality metrics are maintained, and all compliance performance and potential risks are identified and communicated with the Senior Management team.

 

Skills/experience:

  • Scientific degree (ideally Pharmaceutical Science; Biology; Chemistry; or similar) 5+ years’ experience gained successfully managing quality issues within either a biotechnology or biopharmaceutical environment Proven track record of defining, implementing and maintaining Quality Management Systems Experience of managing the quality performance of internal functions, external service providers and external audits In depth knowledge of GCP requirements (biologics) and relevant industry and regulatory guidelines governing clinical trials in Europe and USA, and GLP and cGMP requirements related to the manufacture of biologics in the UK, Europe and USA Understanding of GLP and GMP requirements (biologics) Fluent in English. Additional languages are advantageous

 

Please note, we are unable to consider applicants who do not have the right to work in Switzerland.

 

Company

At Albion Rye Associates, we create a bespoke recruitment process that is thorough, professional, personable – and most importantly, tailored to exactly to what you need.

We have a clear focus on collaboration and communication. We are solutions-led and know from vast experience that for successful outcomes to be reached, we don’t just work for our clients and candidates – we work with them.

Our valued clients and candidates have the highest of standards and expectations. We are exactly the same. If we weren’t, they wouldn’t want to work alongside us. We ensure that every client and candidate receives the made-to-measure, personalised recruitment service that they want, need, and deserve through building long-term working relationships.

Company info
Website
Location
CoTribe Offices – Raven House
29 Linkfield Lane
Redhill
Surrey
RH1 1SS
United Kingdom

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