QC Validation Manager - 1 year FTC

Purpose of Job

The QC Validation manager is responsible for the validation and transfer of novel and established test methods for the analysis of gene therapy products and associated materials used for manufacturing the EU and FDA GMP requirements at both the Meiragtx UK and Ireland sites. The role involves life cycle management of assays, equipment and materials/products.

Major Activities

• Lead the development and validation of established and novel analytical test methods for the current and newly developed gene therapy products.

• Serve as the subject matter expert for lifecycle management of analytical assays, equipment and materials including in-process samples and finished products.

• Generate qualification/validation projects and associated documentation in support of the analytical activities performed ensuring compliance requirements are maintained.

• Ensure all methods are validated and performed in the QC GMP labs in compliance to regulatory standards and adheres to data integrity requirements.

• Support Validation of Methods for raw Materials testing & sampling booth activities.
• Responsible for the project management of test method implementation to required timescales to ensure seamless launch of new products.
• Responsible for ensuring any external testing activities meet GMP requirements.
• Maintain the flow of information to key stakeholders, ensure appropriate communications are passed forward and information folders are maintained with most recent versions/communications
• Ensure the development and rollout of training on new technology/methodology introduced to the facility.
• Perform routine assessment of the analytical methods used to ensure they are being applied and are operating as expected.
• Support any training activities of other employees where required.
• Support with maintaining Quality Management System and controlling of documents and ensuring the data integrity of all data produced.
• Support with all reasonable managerial requests and ad-hoc tasks.
• Ensure area compliance with Quality, Safety and Environmental systems and procedures.
• Comply with MeiraGTx procedures including Health and Safety and GMP.
• Ensure own KPl’s plans, targets and objectives are effectively tracked, monitored and achieved in accordance with timelines.
• 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.

Key Job Competencies

• Implement/qualify/validate analytical methods for the GMP testing of products and aseptic manufacturing facilities - understanding of regulatory requirements for analytics and stability for ATMPs.

• Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions and works well in group problem solving situations.

• Leadership - exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.

• Cost consciousness - works within approved budget; develops and implements cost saving measures; contributes to profits and revenue; conserves organizational resources.

• Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence.

• Planning/Organising - prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.

• Professionalism - approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.

• Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness. •
• Oral Communication - speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.
• Written Communication - writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.

Job Background

• Degree in Human Health or Sciences equivalent relevant work experience in the pharmaceutical or other similar regulated industry (i.e. biologics).

• Demonstrate significant experience in a validation role in the pharmaceutical or other regulated industry.

• Must have previously managed a team of people.

• Proven ability to deliver key projects on time.

• You are independent, enthusiastic, goal-oriented, efficient, and accurate, and enjoy working in a fast-paced environment.
• You can run several projects in parallel and working in a flexible way.

• Proficiency in a body of information required for the job e.g knowledge of EU and FDA regulations, GMP/GLC/GCP, Lean Manufacturing, Six-Sigma, etc.

• Proficiency in IT, Microsoft Office software (Word, Excel, Powerpoint) preferred.

• Must be willing to travel between the two Meiragtx sites.