QA Operations Team Manager

Your mission

Purpose of Job The QA Operations Team Manager is responsible for providing first line QA Support and oversight of the Meira

GTx 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.

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 Meira
  
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• 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 thinker 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…