Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.
Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.
An opportunity has arisen for a QC Lab Manager (Micro) to join our team in Livingston based team on a 12 month fixed term contract.
To provide oversight and co-ordinate the routine running of the QC Microbiology. Provide technical expertise and guidance to support Sterility Assurance, Microbiology and Facility Contamination Control (FCC) initiatives on site.
- Ensure that EOHS requirements are met by the team, including individual/team training, and that any incidents are investigated and reported in a timely manner to the Head of Quality Control and the EOHS department.
- To manage Microbiology activities in support of manufacturing schedules and support FCC activities
- Oversee the execution of microbiology activities according to defined SOPs and protocols with timely reporting of issues to relevant staff
- Provide support as Subject Matter Expert (SME) in microbiologically related investigations and other problem solving forums
- Maintain knowledge and competence to undertake tasks within the team, for example, at times of absence or high workload
- Ensure testing in the microbiology laboratories is scheduled and performed in a timely manner and in alignment with the Manufacturing Master Planning Schedule
- Manage and maintain facilities, resources and equipment required to adequately support microbiology activities
- Ensure direct reports are appropriately trained and competent in the procedures they are conducting, and are in compliance with cGMP working practices at all times
- Immediately escalate and report any deviations to materials, facilities, processes or procedures to the Head of Quality Control, Head of Facility Contamination Control (FCC) and Qualified Person (QP)
- Manage and co-ordinate on time delivery of QMS documentation by the team
- Ensure the principles of Data Integrity are deployed within the team and that issues are escalated to the Head of Quality Control in a timely manner
- Ensure high standards of housekeeping are maintained within areas of responsibility
- Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative team within QC
- Develop, collate and report key quality/business related metrics, and use such metrics to drive a culture of continuous improvement and process efficiencies within areas of responsibility
- Contribute, encourage and support staff development activities
- To undertake any other duties as requested by the line manager in accordance with company requirements
- Support shift and out of normal hours work, including weekends, as required to support business requirements
- Deputise for the Head of QC during times of absence or a need for technical expertise
- Educated to degree level or equivalent experience
- Experience within a QC Laboratory working to GMP within a recognised quality system (3+ years)
- Knowledge of GMP guidelines and regulatory bodies
- Previous supervisory experience in a lab environment preferred
- Ability to lead and co-ordinate work within a busy QC laboratory
- Ability to motivate and engage an effective workforce
- Ability to develop and manage change projects effectively and efficiently
- Effective communication and presentation skills (for internal and external interactions)