MAH Project Manager

GREAT ORMOND STREET HOSPITAL NHS FOUNDATION TRUST; Camden Town; On-site; GBP 60,000 - 80,000; Full time

Job summary

A prominent children's hospital in Camden Town seeks a motivated Project Manager to oversee the development of compliance systems for advanced therapies. The ideal candidate will have a proven track record in project management and experience in GXP quality systems. This role offers a unique opportunity to contribute to transformative healthcare solutions and enhance diversity in the workplace.

Qualifications

• Experienced in project management with a strong track record.
• Knowledge of GXP quality systems and pharmacovigilance.
• Experience with post-authorisation regulatory management is an advantage.

Responsibilities

• Develop project implementation plans and budgets.
• Work with internal teams to establish regulatory compliance systems.
• Support planning for market authorisation applications.

Skills

Project management

GXP quality systems

Pharmacovigilance

Job description

Overview

The project manager will work together with the MAH Project Lead and multiple internal and external teams to develop a pipeline model of sustainable manufacture and delivery of advanced therapies with a not-for-profit approach.

The initial stages of the project will require development of user requirement specifications and solution scoping for the systems and infrastructure required for GOSH to establish itself as a marketing authorisation holder. These will include a regulatory compliance and information management system, a GVP compliant pharmacovigilance system for licensed medicinal products, and a patient registry data collection tool required to provide ongoing safety monitoring of ATMPs following market authorisation. The project manager will work closely with the MAH Project Lead and internal teams to develop detailed project implementation plans and budgets needed to establish these systems and infrastructure.

The project manager may also be involved in supporting the planning and preparation of a market authorisation application and NICE Health Technology Appraisal for a candidate gene therapy.

The postholder will be an experienced highly motivated and capable individual with a strong track record in project management, GXP quality systems and/or Pharmacovigilance. Experience with post authorisation regulatory management of medicinal products would be an advantage.

About GOSH and the MAH Project

For over 20 years, GOSH working in partnership with the Great Ormond Street Institute of Child Health (ICH), has been at the forefront of developing and delivering transformative gene therapies for rare, inherited diseases. The new Cell & Gene Therapy Good Manufacturing Facility in the Zayed Centre for Research has been opened to build on this expertise and to increase the capacity and broaden the scope for manufacturing at GOSH. As part of GOSH's commitment to tackling rare childhood disease, GOSH is embarking on an ambitious project (GOSH MAH Project) to address a critical need in the rare disease space not adequately met by commercial entities due to economic constraints. In the current healthcare landscape, despite their clinical effectiveness, certain rare disease advanced therapies have been withdrawn by commercial developers due to a lack of commercial viability. GOSH is committed to finding an alternative approach to prevent these proven treatments failing to reach patients.

Diversity and Inclusion

We are keen to make our workforce as diverse as the communities we serve, and we hope to attract applications from underrepresented groups, including people with Black, Asian and Minority Ethnic heritage, people with a disability, and people from LGBTQ+ communities. By growing an ever more diverse workforce, we'll have a greater range of perspectives and knowledge, meaning that we can provide the children and young people at our hospital with even better care.

Our hospital is committed to creating an environment that is open and inclusive. Our staff are encouraged to engage with colleagues through the following networks: REACH (Race, Ethnicity and Cultural Heritage) ENABLED (Enhancing Abilities & Leveraging Disabilities Network), PRIDE and Women's networks; all of which are sponsored by a member of our Executive Management Team. We want to ensure that all of our people, regardless of their background, are seen and heard. We want to attract applicants that share our commitment to inclusion and that understand diversity is a strength that is embraced and valued.