Liverpool, ENGLAND, United Kingdom
Are you looking for a rewarding career in a market-leading and innovative company?
Seqirus is the new global company created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis. In July 2015, bioCSL and the influenza vaccines of Novartis joined forces to create what is now the second largest influenza vaccine company in the world. With extensive research and production expertise and manufacturing plants in the US, UK, Germany and Australia, Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. Seqirus has a workforce of over 2,000 employees, significant manufacturing capacity and a commercial presence in 20 countries.
Currently for our site in Liverpool, UK we are looking for a:
Quality Lead - Project and Technical Support
This is initially a 6-month fixed term contract role.
To provide technical support and quality guidance to the organization on a wide ranging portfolio of projects and business improvement activities.
To ensure that appropriate quality standards and systems are in place, and applied across the site operations in accordance with regulatory and Seqirus global requirements.
To drive continuous improvement to enable best in class performance in Quality, Customer service, Financial and HSE performance goals.
To provide leadership for all QA associates and to ensure that they are fully trained, developed and motivated to achieve their full potential.
To be an effective and respected member of the Quality Assurance leadership team.
To participate in a diverse and wide ranging portfolio of projects; some in an advisory capacity level and some as project lead.
To ensure that projects and business improvement opportunities are progressed in accordance with the appropriate regulatory standards and Seqirus global requirements.
To provide quality oversight and decision making in relation to technical transfer projects in both manufacturing and quality.
To participate in key business decisions and strategy reviews relating to secondary manufacturing operations at Seqirus Liverpool, and to represent the Quality function during external discussions with customers and vendors.
To establish quality objectives and KPI's for the relevant QA function are met and to ensure these objectives are met and that continuous improvement is demonstrated.
To ensure an effective Quality & Compliance Management Review process is in place.
To provide QA oversight of site review meetings such as DRB, STAG, Continuous Process Verification and Change control committee.
To promote a culture of operational excellence including Lean and Six Sigma through the application of IQP programmes.
To oversee the effectiveness of the GxP training programme for associates.
To recruit, motivate, lead and develop the Quality team.
To ensure that the relevant Quality function is managed in a cost effective manner in line with the approved budget and efficiency improvement targets.
To develop and maintain a relationship with regulatory authorities including participation in the inspection process site audits as appropriate.
To ensure the correct management of third party distributors and fill finished contract manufacturers in accordance with Seqirus policies and procedures.
The role holder will possess all or most of the following:
A degree or equivalent in a life science.
Preferable, the candidate should meet the requirements for EU Qualified Person.
Essential that the role holder has substantial industry experience in aseptic manufacturing, particularly in fill finish operations.
It is preferable that the role holder has experience of biological pharmaceutical products.
Excellent pragmatic decision making skills are required as the role holder will be autonomous in making key quality and technical decisions on the projects assigned.
Ideally, experience of project management and/ or taking a lead role in complex projects.
A commercial outlook with attention to detail.
A proactive approach which builds Quality & Compliance into processes.
A track record in cementing teams, and delivering outstanding effectiveness from those teams.
The ability to deal with complexity and uncertainty and to remain calm under pressure.
A good track record with the FDA, MHRA, EMEA and other regulatory agencies.
A good understanding of foundation principles of Lean & Six Sigma.