QA Operations Team Manager

Your mission is to ensure the QA Operations Team Manager provides 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 compliance with applicable EU, UK and US GMP regulatory requirements.

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 site's 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 events and CAPA.
• Provide training and support for quality relevant systems in the UK, USA and Ireland.
• Ensure adequate resources are available to support 'Quality on the shop floor' culture and facility walkarounds 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 manner 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 to 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 representing the QMS team and escalating blockers to the Quality Director as required.
• Oversight, review, and management of 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, onboarding, mentoring, coaching, annual objective setting, performance management and employee development.
• Develop and deliver GXP compliance training to operational areas.
• Actively develop, mentor, train and instil a quality culture within MeiraGTx.
• Ensure that own work and team's work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents.
• Ensure own team's training is undertaken in a timely and GMP compliant manner before that task is undertaken.
• Ensure own team's KPIs, 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 and organising priorities and plans work activities.
• Excellent interpersonal skills.
• Able to prioritise workload, decisive thinker able to work within agreed timescales.
• A high level of attention to detail.
• Knowledge of GMP with regards 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, e.g., 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 outlined in UK 'Orange Guide', EU 'Eudralex Volume 4', US 'CFRs' and other relevant regulations/guidelines.
• Working and hands-on experience with defining and implementing Quality Management systems.
• Leadership and management experience of successfully 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 behaviours.
• Pragmatic/common sense approach to quality incidents.