Senior Quality Manager - Systems & Compliance

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.

• 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.

• 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 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 be able to achieve their goals and objectives.

• 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. 21
  
  CFR 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.