Senior Quality Manager - Systems & Compliance

Meiragtx; Greater London; On-site; GBP 110,000 - 150,000; Full time

Job summary

MeiraGTx is seeking a senior QA leader to maintain and improve GxP Quality Systems, ensuring ongoing inspection readiness across the organization. You will train functions in QA practices and supervise a QA System and Compliance team to ensure regulatory compliance.

Key duties include updating procedures to align with current regulations, reviewing regulatory updates, and preparing for audits with both regulators and partners. A science-based background and 10+ years in QA are preferred.

Qualifications

• Extensive knowledge of GxP regulations in operations (manufacturing/testing).
• Experience implementing simple, robust Quality Management Systems.
• Ability to host and follow up regulatory inspections/audits.
• Strong decision making aligned with quality risk management.

Responsibilities

• Line management of the QA System and Compliance team as defined in the org chart.
• Ensure positive outcomes for regulatory inspections and client audits.
• Manage workload to meet timelines and priorities, elevating issues when needed.
• Promote collaboration and quality coaching across the business.

Skills

GxP knowledge

Quality Assurance

Audit readiness

Leadership

Quality culture

Education

BSc/MSc in Science

Job description

Location: London
Employment type: 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 collaboration 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.

Key Job Competencies

• Extensive knowledge and experience within pharmaceutical Quality Assurance and GxP regulations within an operations environment (manufacturing and 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 following 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\".

Job Responsibilities

• Line management of the QA System and Compliance team as defined in the org chart.


• Ensure a positive outcome for any regulatory inspections and 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 elevate 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 achieve their goals and objectives.

Job Background

• Science based degree e.g. BSc or MSc.


• Substantial Quality Assurance experience of 10 years and knowledge of GxP Operations and Quality Systems required for a sterile manufacturing facility, applying and understanding 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, with 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 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.