Major Activities

• Review and approve Quality Control documentation ensuring timely and adequate release of GMP compliant product in accordance with product specifications.
• Provide line management to member(s) of the incoming material inspection department to contribute to the overall group objectives.
• Plan and assign work to the team to achieve the most efficient use of personnel and resources. 
• Overseeing the incoming material inspection department to support the seamless supply of materials for the manufacture of drug product.
• Ensure all direct reports or persons involved in projects are fully trained and maintain a high standard of record keeping and documentation so that information is clearly captured, disseminated, and reported.
• Support the development and implementation of quality control documentation/continuous improvement programmes.
• Contribute to the training and development of others.
• Promote appropriate, effective communication within the team, with members of other departments, and with external collaborators.
• Contribute to cross departmental activities and providing expert advice and technical input where needed.
• Assure the data integrity of all activities performed.
• Ensure area compliance with Quality, Safety and Environmental systems and procedures.

Materials Department

• Perform inspection, and release of incoming materials, following SOPs and GMP practices to ensure seamless supply of material to support aseptic manufacture of ATMP product.
• Set up, Control, and monitor the material inspection programme ensuring materials are suitable for the manufacture of gene therapy products to the required standards.
• Physical inspection of raw materials. Ensure the warehouse storage environment is acceptable for the materials being inspected (Can be multiple warehouse locations).
• Set up, monitor, and coordinate incoming material testing where required.
• Maintain all incoming material documentation meets GMP requirements. 
• Ensure adequate control of the material status for release or reject.
• Comply with MeiraGTx procedures including Health and safety and GMP.
• To ensure all equipment used is calibrated/maintained and in line with SOP’s.
• Identify and report procedural problems and deviations.
• Participate in the planning of duties to ensure the facility is acceptable and customers receive products on time and in full.
• Any other duties/projects within the skills and ability of the post holder.
• Identify and support method/technology improvement activities and facilitate implementation into the microbiology department.

Key Performance Indicators

• HR process compliance
• Staff turnover rate
• Material release KPIs
• GMP compliance 
• Data integrity

Key Job Competencies

• Experience of working within a GMP manufacturing environment.
• Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
• A high level of attention to detail.
• Problem Solving - Identifies and resolves problems in a timely manner; able to gather and analyse information; develops alternative solutions; works well in group problem solving situations.
• Leadership - exhibits confidence in self and others when leading a team of people and managing processes.
• Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence.
• Planning/Organizing - prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives.
• 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.
• Innovation - meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
• Oral Communication - speaks clearly; 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.
• Physical & mental requirements - occasional lifting; the noise level in the work environment is usually moderate.

• Team of Materials Scientists/Technicians
• Compliance with GMP
• 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.

Job Background

• Supervisory and/or management experience of people and/or processes.
• Minimum 3 years’ experience working in a GxP environment.
• Experience of quality documentation and batch release.
• Proficiency in Microsoft Office software (Word, Excel, and PowerPoint) preferred.