RBW are supporting a clinical-stage gene therapy company in London. They are in an active growth phase, with programs at various stages of development for a range of indications, including inherited ophthalmic diseases and CNS diseases.
With a global footprint, the successful commercialization of their products will have a wide-reaching impact, due to the high potential that gene therapy has to provide meaningful clinical benefits in these areas. Their state-of-the-art manufacturing facility was designed to meet global regulatory requirements and has the capacity to produce sufficient products for all clinical trials and scale to commercial capacity.
In preparation for this exciting future, my client are currently seeking a Senior Manager to oversee their Compliance and Quality Systems. The position is responsible for the maintenance and continuous improvement of the QMS, ensuring they always remain complaint and inspection ready.
The position will have line management of the Validation, QA CSV and Supplier Quality teams and provide QA support and training to all functions
- Responsible for the maintenance and continuous improvement of the Quality Systems on site ensuring in compliance with current regulations and standards.
- Owner of the Quality Council process, ensuring slides are prepared and notes and actions are followed up
- Manage the self-inspection programme including adherence to the schedule and preparing the schedule using a risk-based approach.
- Responsible for the Validation, Supplier Quality and CSV teams.
- Owner of the Risk Management process
- Host and SME for regulatory and partner inspections.
- Prepare site for inspection readiness
- Responsible for regulatory update implementation into site, working with departments to ensure procedures and processes are updated
- Management and oversight of key quality meetings on site including Change Control and Product Quality Reviews
- Management of Audit findings, working with key stakeholders and SMEs to define and close out
- Management of metrics on site ensuring performance is visible to all employees within GMP.
- Interact with colleagues in other function to increase the overall effectiveness of the QA department and identify process improvements/efficiencies
- Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP)
- Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner
- Responsible for ensuring that any GMP documentation e.g. Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, is closed timely and in a RFT state
- Science based degree and substantial biopharma Quality Assurance experience, with knowledge of GMP Operations and Quality Systems required for a sterile manufacturing
- Strong working knowledge of the principles and guidelines for GMP as set out in the Orange Guide, Eudralex Volume 4, U.S. 21CFR part 210/211 etc
- Extensive knowledge and proven track record of implementing Quality Management Systems which are simple, robust and in compliance with applicable cGxP regulations and guidelines
- Knowledge of preparing for, hosting and follow up on regulatory inspections
- Demonstrated ability to make sound decisions regarding evaluation of GMP compliance, and leadership abilities in the management of QA oversight
- Holds self and others accountable in achieving goals, with a proven track record of developing and leading a high-performance team
- Strong leadership skills with good collaboration, communication and problem-solving skills
- Strong interpersonal skills, able to establish and maintain effective working relationships with internal and external peers and stakeholders
This role offers hybrid working, based in the Central London office, with 3-4 days on-site, and the rest WFH. The salary on offer is strong in the current market, and the benefits package includes a bonus, LTIs, generous pension, private healthcare, and employee wellbeing benefits.
Please apply today, or contact email@example.com or +441273 952176 for more information.
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