QA Operations Team Manager

Permanent employee, Full-time · London

Your mission

Purpose of Job

The QA Operations Team Manager is responsible for providing first line QA Support and oversight of the MeiraGTx Quality Management System ensuring it is inspection ready and maintained in a state of control in compliant with applicable EU, UK and US GMP regulatory requirements.

Lead, manager and train the QA Operations and Documents Control, Continuously improve the Operational Quality System and provide training and support for Quality relevant to operations. Set objectives for the QMS System.

Ensure regulatory compliance and product quality requirements are met at all times, as well as facilitating QP product release and certification in a timely manner.

Role is based in the UK, covering UK operations, providing support to Ireland and USA sites as necessary.

Job Description

Major Activities and Responsibilities:

Provide leadership, guidance and direction to the QA Operations and Documents control team to ensure smooth daily operations and continuous improvement.
Act as a primary point of contact for all operational issues.
Develop, maintain and manage the sites internal audit/self inspection schedule. Ensure the timely execution, reporting and follow up on findings to ensure inspection readiness.
Approve and support investigation of significant quality evenings and CAPA.
Provide training and support for quality relevant systems in the UK, USA and Ireland.
Ensure adequate resource is available to support ''Quality on the shop floor' culture and facility walk. arounds to maintain a high level of compliance. Collaborate with operational teams to ensure any potential issues are remediated to minimise impact.
Ensure batch records are reviewed in a timely manage to facilitate timely batch release.
Generation, review and approval of relevant GMP documentation.
Act as a primary point of contact for external partners, specifically for matters relating to quality events and out of specifications.
Assure compliance t EU and FDA regulations/standards to ensure retention of MIA (IMP) and MS Licences.
Act as SME for the quality management systems and documentation processes at regulatory and 3rd party audits.
Participate and aid in preparation of the data for Quality Council.
Ensure Tier 1 meetings are held daily for the QMS Team.
Participate in Tier 2 meetings (including campaign readiness and scheduling meetings) representing the QMS team and escalating blockers to the Quality Director as required.
Oversight, review, and management risks, Quality events including incidents, deviations, investigations, change controls and CAPA ensuring they meet timelines.
Coordinate preparation activities for regulatory inspections and [provide support to regulatory inspections as required by the Quality Director.
Management of the people process, hiring, on-boarding, mentoring, coaching annual objective setting, performance management and employee development.
Develop an deliver GXP compliance training to operational areas.
Actively develop, mentor, training and instil a quality culture within MeiraGTx.
Ensure that own work and teams work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents, eg, SOP's, BMR'S Protocols, Guidance's, etc.
Ensure own teams training is undertaken in a timely and GMP Compliant manner before that task is undertaken.
Ensure own teams, KPI's, plans, targets and objectives are effectively tracked, monitored and achieved in accordance with timelines.
Deputise for the other QA Leaders.
Perform other QA Related tasks as assigned by the Quality Director.

Key Competencies:

Experience in leadership and team development
Strategic thinking and risk management
Experience of working within a sterile/Aseptic GMP manufacturing environment.
Understanding controlled processes.
Proficient in Microsoft office and experience in database and eQMS systems.
Planning. Organizing priorities and plans work activities, uses time efficiently. plans for additional resources, sets goals and objectives, organises or schedules other peoples tasks , develops realistic action plans.
Excellent interpersonal skills.
Able to prioritise workload, decisive thinkner able to work within agreed timescales.
A high level of attention to details.
Knowledge of GMP with regard's to QMS Activities.
Good team player and must be able to work alone.
Experience in competent authority, regulatory body inspections and audits.
Ability to work in a fast paced environment

Job Background:

Relevant science based degree, eg, chemistry, Biology, Pharmacy.
Experience working in a GXP environment including a minimum of 6 years experience in compliance and quality assurance.
Working knowledge of the principles and guidelines of cGMP as out in UK 'Orange Guide, EU, 'Eudralex Volume 4'', US 'CFR's' and other relevant regulations/guidlines.
Working and hands on experience with defining and implementing Quality Management systems.
Leadership and Management experience of successful managing small teams is preferred.
IT Literate, experience managing and operating an electronic QMS.
Excellent verbal and written communication skills.
Excellent interpersonal skills with the ability to appropriately challenge other behavioural
Pragmatic/common sense approach to quality incidents.

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About us

MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.

Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.

Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.

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We are looking forward to hearing from you!

Thank you for your interest in MeiraGTx. Please fill out the following short form. Should you have difficulties with the upload of your data, please send an email to talent@meiragtx.com