We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. Our focused pipeline includes the world’s first vaccine against the chikungunya virus, the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats.

Please find a link to our corporate video for a quick insight into Valneva

Our Quality Assurance team are currently recruiting for a QA Supervisor to supervise, guide and manage the tasks and workloads of the QA teams.

Working both individually and in collaboration to effectively plan and track all activities for their teams to maintain the compliance of manufacturing and all associated support activities, batch release, and regulatory requirements in the Valneva Scotland facility.

Requirements

Provide direct line management to one of two teams of Quality Assurance/Operations Specialists, reviewing individuals’ performance regularly to ensure the development of individuals’ skills/knowledge. Complete performance reviews as per site requirements.

Plan, organise, and track team routine daily activities with the other QA Supervisor to ensure on-time completion to meet site requirements. These activities include but are not limited to:

• Batch record review.
• Coordination of activities to ensure the effective operation of QMS.
• Review and closure of Site QMS.
• Review of new and updated documentation.
• Batch release activities.
• Temperature excursion.
• Product technical complaints.
• Validation.
• Internal/External Audits and In process inspections.

Plan, organise, and track team routine daily activities to ensure all QA QMS is completed on time.

Each QA Supervisor will take ownership of team-specific processes as defined by the Head of QA. They will plan and track activities to ensure delivery within required timelines and define, measure, and report appropriate key quality metrics for these systems to the Head of QA to demonstrate compliance and show ongoing continuous improvement. These specific systems/areas include but are not limited to:

• Supplier Assurance.
• Internal / External Audit Process.
• Deviations / Investigation.
• Data Integrity.
• Software projects/IT compliance.
• Batch Release.
• Change Control (SmartChange).
• Training (SmartTrain).
• Document Control (SmartDoc).
• Validation.

Each QA Supervisor will provide support to the Head of QA in relation to regulatory inspections by supporting preparation, hosting, back-room support, responding to observations and closure of actions as required.

Represent/provide support for another QA Supervisor when required

Train, coach, and mentor team members to ensure all department requirements are met on an ongoing basis with no disruption to business needs.

Perform documentation reviews in accordance with relevant Standard Operation Procedures, including but not limited to:

• CAPA
• Change management
• Investigations
• Complaints (customer/supplier)
• Supplier assurance processes
• Batch review/certification responsibilities

Support the ongoing QA Site training program as a trainer in key QA systems/areas

Each QA Supervisor will act as a Valneva Scotland contact in assigned QA processes with other Valneva Sites:

• Ensuring good collaboration and effective working relationships.
• As appropriate ensuring knowledge of reciprocal QA Supervisor processes.

Each QA supervisor will provide QA representation for site projects and plan and track to ensure QA team project actions are delivered to meet the project timelines

Provide support for the delivery and presentation of key quality metrics for the site and QA department for presentation and discussion at the monthly QRB meeting.

Provide active contribution to the development and maintenance of a good Quality Culture on-site through effective collaboration and communication with other departments.

To undertake any other reasonable duties as requested by the Head of Quality Assurance, in accordance with company requirements

Extended hours and out-of-normal working hours work may be required

Benefits

• Stock Options
• Employee Assistance Programme
• Gym membership OR fitness allowance
• Free Fruit
• Many others included