• Lead the Quality function of company’s GMP Facility for the manufacture of Advanced Therapy Medicinal Product. 
• Ensure continuous compliance with regulatory requirements and expectations from regulatory authorities and customers. 
• Act as a role model to drive quality within the organisation by providing leadership, oversight and management of the Quality Assurance function within and towards company's customers and suppliers.  
• Responsible to authorise the release of product supplied by the company.  

• Responsible for the release of product supplied by the company ensuring that the product meets quality and customer specifications. Responsible for the issue Certificates of Conformity.
• Responsible for the Maintenance the Pharmaceutical Quality System, Quality Manual, Site Master File, Regulatory Filings, Licence maintenance, Quality Risk Management and all other aspects of the Quality System. 
• Champion a culture of continuous improvement of company’s best practices through company’s Pharmaceutical Quality System.  
• Ensure that product is released in a timely to meet business targets. 
• Responsible for the timely review and approval of all quality related documentation with the organisation ensuring the Quality Assurance and Quality Control departments are sufficiently resources to achieve these targets. 
• Responsible for the Quality Control Function. 
• Responsible for Environmental Monitoring of the Aseptic Manufacturing Facility and ensure timely collection and analysis of all sampling whether this performed internally by the company or by external parties.
• Act as a key member of the Operational Management Team.
• Maintain quality metrics to support the continuous monitoring and improvement of company's quality objectives.
• Responsible for organising Management Review and compiling and reporting on the performance of the quality system.
• Act as the main point of contact for quality for regulatory authorities and customers and liaise with authorities and customers on these matters.
• Responsible for timely issue of audit responses and closeout of any audit actions.
• Ensure that customer requirements as documented in Quality Technical Agreement are met.
• Responsible for the self-inspection system.
• Responsible for Product Quality Reviews 
• Responsible for Change Control and Deviation Management providing assistance, where needed, with the closeout of Deviation Investigations, Root Cause Analyses and Change Control tasks.
• Actively culture of continuous professional development of the quality team keeping up to date with current Quality Standards and regulatory requirements and expectations. Responsible for the knowledge development of the Quality team with regard to product technical manufacturing knowledge and aseptic processing. Ensure information sources, for example through websites, journals and the pharmacopoeias are current and available. 
• Responsible for Supplier Quality Management. 
• Ensure that Health and Safety procedures are adhered to at all times and that, as a minimum, all legislative requirements are adhered to. 
• Responsible for timely issue of audit responses and closeout of any audit actions.
• Ensure that customer requirements as documented in Quality Technical Agreement are met.

• Accountable to – Management Committee.
• Internal – all levels of personnel and management.
• External – Regulatory Authorities, customers and suppliers

• Extensive experience in quality assurance and/or quality control of aseptic products for human use.
• Experience with leading audits for regulatory authorities
• Proven management experience

• Team orientated. 
• Methodical, organised with an aptitude for attention to detail.
• Flexible and willing attitude
• Extensive Communications skills with the ability to interact with all levels of the organisation.
• Able to work under pressure and co-ordinate several activities concurrently.