Major Activities and Responsibilities

• Responsibility for the QMS System within area of responsibility, ensuring that it's fully deployed, up to date and maintained in a state of compliance.
• Promote a “Quality Mindset” with peers and stakeholders by providing proactive thinking and strong input and guidance to situations that arise that require in-depth knowledge of GCP/GCLP/GLP regulations and MeiraGTx QMS
• Provide CQA oversight and support to Pre-Clinical and Clinical Operations teams in MeiraGTx.
• Provide CQA oversight and follow up on 3^rd party vendor and suppliers (CRO’s, CMO’s, etc.) performance.
• Act as QA representative in clinical project meetings providing input and guidance to the clinical operations teams to ensure compliance throughout the project lifecycle.
• Act as QA lead on all clinical quality matters relating but not limited to regulatory submissions, clinical protocols and the conduct and reporting of clinical trials.
• Contribute to the selection of and ongoing auditing of key suppliers, vendors, CROs and Clinical labs
• Ensure there is a system in place to support and/or execution of audits e.g.: investigator site, vendor, internal process, systems, clinical trial documents.
• Manage, escalate and host the Clinical Review Board Escalation process in response to any identified critical/serious quality incidents related to clinical operations.
• Prepare for, and host, regulatory inspections within GCP requirements. Ensure any findings reported in such inspections are appropriately remediated in a timely manner.
• Drive communication with global QA colleagues to ensure consistency in the application of the Quality strategy and to promote standardisation within the business.
• Collaborate and support pre-clinical and clinical senior management and staff to assure compliant performance of clinical studies.
• Provide training and mentorship, develop and deliver awareness sessions on various GCP/GCLP/GLP topics.
• Responsible for ensuring that own work and that of the team complies with Data Integrity and Good Documentation Practice (GDocP) 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 compliant manner before the task is undertaken.
• Ensure own KPI’s, plans, targets and objectives are effectively tracked, monitored and achieved in accordance with timelines.
• Can deputise for other members of the Global Quality Leadership Team

Key Job Competencies

• Extensive knowledge and understanding of pharmaceutical Quality Assurance for GCP, GCLP and GLP. This knowledge must be combined with clear decision making, pragmatism aligned with quality risk management principles to demonstrate and ensure that clinical trials (Phase I, II and III) sponsored by MeiraGTx are compliant.
• Extensive knowledge and proven track record of implementing Quality Management Systems which are simple, robust and in compliance with applicable regulations and guidelines.
• Extensive knowledge and experience in auditing requirements – Lead Auditor GCP/GCLP/GLP
• Awareness of preclinical quality standards and good practices for research
• Extensive knowledge of working with or within CROs organisations
• Knowledge of preparing for, hosting and follow up on regulatory inspections.
• Seasoned leader who has been part of Senior management teams and are able to contribute to the development and implementation of operational strategy of the company with emphasis on quality requirements, research, product development activities and commercialisation.
• Ability to interpret complex data and present key findings.
• Must have a hand on approach, and experience with building a “Quality Mindset” for team members who has not worked within a GxP environment.

Job Responsibilities

Job Background

• Science based degree e.g. BSc or MSc
• Minimum 10 years’ experience working at senior management level in a pharmaceutical/biopharmaceutical Quality Assurance GCP/GCLP/GLP function.
• Extensive knowledge, and hands on understanding and application of GCP/GCLP/GLP regulations and substantial experience with defining and harmonizing Quality Management Systems combined with a proven track record of having successfully implemented these.
• Strong interpersonal skills must have the ability to establish and maintain effective working relationships with internal and external peers and stakeholders.
• Experience with hosting and follow up on corporate audits, client audits and regulatory inspections.