Associate Director - QA Compliance and External Quality

Purpose of Job

• 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.

Major Activities

• 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. Ensuring KPIs are clearly defined and managed.
• Owner of the Risk Management process
• Host and SME for regulatory and partner inspections.
•  Prepare site for inspection readiness, ensure readiness is tracked and visible to the leadership team on site.
• Responsible for regulatory update implementation into site, working with departments to ensure procedures and processes are updated accordingly in a timely manner.
• 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 as required.
• Responsible for Supplier Quality compliance and adherence to audit schedule. Performing Audits of 3^rd party suppliers and vendors.
• 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) and is undertaken in accordance with applicable procedures
• Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner before the task is undertaken
• Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a RFT state
• Deputise for the Quality Director when required.

Key Job Competencies

• Extensive knowledge and understanding of pharmaceutical Quality Assurance and GMP experience within an operations environment. 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
• Knowledge of preparing for, hosting and follow up on regulatory inspections
• Flexibility to meet changing needs and priorities of the business
• Must have a hands on approach, and experience with facilitating a Quality Culture and building a “Quality Mindset” for team members who has limited experience or not worked within a GxP environment.

Job Responsibilities

• Line management of the Validation and Supplier Quality teams as defined in the org. chart.

Job Background

• Science based degree e.g. BSc or MSc
• Substantial Quality Assurance experience 10 years’ and knowledge of GMP 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 GMP 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 GMP 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
• 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