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Senior Quality Manager - Systems & Compliance

London
Full-time
Permanent employee

Your mission

Responsible for the maintenance and continuous improvement of the GxP Quality Systems at MeiraGTx to ensure they remain complaint and inspection ready at all times. Providing ongoing support and training to the functions across MeiraGTx with regard to Quality Assurance. Ensure MeiraGTx remains inspection ready at all times. 
  • Actively reviewing and implementing regulatory updates in collaborations with the teams on site.
  • Updating procedures and processes on site in line with the current regulations.
  • Preparing for and managing regulatory and partner audits.

Job Description

 Key Job Competencies

  • Extensive knowledge and experience within pharmaceutical Quality Assurance and GxP regulations within an operations environment (manufacturing & testing). This knowledge must be combined with clear decision making, pragmatism aligned with quality risk management principles.
  • Extensive knowledge and proven track record of implementing Quality Management Systems which are simple, robust and in compliance with applicable cGxP regulations and guidelines.
  • Experience in preparing for, hosting and follow up on regulatory inspections and/or client audits.
  • Flexibility to meet changing needs and priorities of the business with a special focus on achieving timelines and deliverables.
  • Must have a hands-on approach, and experience with facilitating a Quality Culture and building a “Quality Mindset”.List key competencies to fulfil role.
 

Job Responsibilities

  • Line management of the QA System & Compliance team as defined in the org chart.
  • Ensure a positive outcome for any regulatory inspections & client audits.
  • Manage the team’s workload in order to ensure the team meets timelines and deliverables as defined by the business. Define priorities and escalate any issues that could impact those to line management.
  • Promote a culture of collaboration and Quality coaching of other areas of the business.
  • Ensure the training needs for the team are met at all times in order to enable team members to be able to achieve their goals and objectives.
 

Job Background

  • Science based degree e.g. BSc or MSc.
  • Substantial Quality Assurance experience 10 years’ and knowledge of GxP Operations and Quality Systems required for a sterile manufacturing facility applying and understanding of the principles of sterile manufacturing.
  • Strong working knowledge of the principles and guidelines for GxP as set out in the Orange Guide, Eudralex Volume 4, U.S. 21CFR part 210/211 and other relevant regulations.
  • Demonstrated ability to make sound decisions regarding evaluation of GxP compliance, and leadership abilities in the management of QA oversight.
  • Is not afraid to make decisions for the group. Holds self and others accountable in achieving goals.
  • 8-10 years experience in line management 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, must have the ability to establish and maintain effective working relationships with internal and external peers and stakeholders.

About us

MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.

Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.

Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.