Associate Director Clinical Quality Assurance

Employer
Albion Rye Associates
Location
Cambridge, Cambridgeshire (GB)
Salary
70,000+
Start date
20 Nov 2023
Closing date
20 Dec 2023

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Discipline
Quality, GCP
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management
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Job Details

Role: Associate Director Clinical Quality Assurance (GCP)

Location: Cambridge, UK or Remote, UK

We are 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 Associate Director Quality Assurance 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, you will work closely with the Clinical Development team to advise on all quality related GCP activities.

Main responsibilities:

  • 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- perform GCP audits if required.
  • 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)
  • Proven track record of defining, implementing and maintaining Quality Management Systems
  • In depth knowledge of GCP requirements (biologics) and relevant industry and regulatory guidelines governing clinical trials in Europe and USA.
  • Understanding of GLP and GMP requirements (biologics)
  • Fluent in English. Additional languages are advantageous

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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