Associate Director – Operational Quality – Cell&Gene sites

Employer
RBW Consulting
Location
London (Greater) (GB)
Salary
£70,000-£90,000
Start date
15 Jun 2022
Closing date
15 Jul 2022

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Management
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Job Details

I’m representing a leading biotech as they seek an Associate Director of Quality in London. This is a permanent role with great growth prospects, as my client expands their existing portfolio and develops an incredible pipeline of Cell&Gene therapies.

 

Reporting to the VP of International Quality, the scope of the role is to support the activation of commercial sites and will help the build-out of the operational support activities for treatment center selection, activation, and quality operational oversight. Additionally, this role will establish the quality risk management plans for each site, and work closely with the technical Apheresis team and the QA audit team on qualifying sites. The position is hybrid in London and from home but will require up to 25% travel to sites in the EU and internationally.

 

This role works closely with the cross-functional teams within QA to will help build the QMS that supports site selection, activation, and monitoring. The person will work on providing compliance expertise that supports investigations and CAPA management and investigation of product complaints.

 

This individual will support Cell and Gene programs in late phase and commercialization. They must demonstrate success in operational excellence, and engage teams and stakeholders for collaboration in advancing quality outcomes.

 

Core Responsibilities:

  • Build out the quality risk management plans and identify mitigation plans
  • Execute the risk management plan to support clinical activities
  • Communicate effectively with senior leaders project plans, compliance risks, and mitigations
  • Work closely with the Audit and Inspection quality function on-site qualifications and establish the audit strategy for Auditing and Performance oversight
  • Establish and maintain Quality Agreements
  • Work with the business areas on site selection
  • Support site inspections- work closely with the cross-business functions and the QA inspection functions to prepare for inspections to respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions
  • Responsible for real-time inspection readiness
  • Site Training and QMS development- support the development of site training by working closely with the Apheresis team
  • Identify and evaluate the maturity of the QMS at the sites and support the remediation of gaps in procedures.

 

Essential Requirements:

  • Relevant degree in a scientific or health field
  • Experience working with biologics and advanced gene therapy regulations
  • GCP and PV experience in Cell& Gene arena and working with clinical sites
  • Background working with CDMOs and management of a manufacturing site.
  • GMP knowledge of CDMO requirements working with Authorised Treatment Centres.

 

This role provides hybrid working from home and a Central London office, and a strong culture with the support and opportunities to progress further into your career. Alongside this, my client also offers a comprehensive benefits package, including a generous bonus scheme, LTI’s, healthcare, and a car allowance.

 

If you have the skills required and have Right-To-Work in the UK, and would like to discuss the full details of the job, please contact Kayleigh on 01293 364095 or apply with your CV.

Company

At RBW Consulting we provide a truly modern approach to recruitment, offering a consultancy based solution to clients and candidates alike which we believe elevates us ahead of all our competitors.  Driven by our five core values, each of our Consultants demonstrates; Growth Mindset, Professionalism, Commitment, Honesty & Fairness to provide the best services we can to everyone we work with.

With unparalleled candidate networks we are the first to hear of new and exciting opportunities in the industry.  All Consultants at RBW focus in their own vertical niche, and it is this way of working which means we can honestly say our Consultants are true experts in their field.  

Our areas of specialism are:

  • Health Economics and Market Access
  • Biometrics
  • Clinical Research
  • Medical Affairs
  • CRO Business Development
  • Regulatory Affairs
  • Data Science
  • Pre-Clinical Research
  • Healthcare Communications
  • Human Resources
  • Patient Recruitment
  • Legal & Compliance
  • Search & Selection

With coverage across the UK, Europe and the United States, RBW consistently has a range of new, exciting and lucrative opportunities on either a permanent or contract basis, from Junior right up to Board level appointments.  To find out more about any of these opportunities, or if you just want to have a general discussion about what is available to you, please call +44 (0) 1293 584 300 or email  info@rbwconsulting.com

 

icon-hub-RBWPlease visit our Careers Hub on

https://www.pharmiweb.jobs/minisites/rbw-careers-hub/

 

 

 

 

Find Us
Website
Telephone
01293 584 300
Location
Origin Two
106 High Street
Crawley
West Sussex
RH10 1BF
GB

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