Qualified Person

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.

We have leveraged our expertise and capabilities both to commercialize three vaccines, including the world's first and only chikungunya vaccine, and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease and Zika.

With operations in Austria, Canada, France, Sweden, the United Kingdom, and the U.S., we are committed to making a positive impact on global public health.

Together, we are a global Company which is open to people of all backgrounds. Our diverse and inclusive workforce makes Valneva a great place to work.

We are currently recruiting for our new QP, please note we can consider applications from both full time and part-time QP's.

Valneva's mission is to help protect the lives of people around the world through the discovery, development, and commercialization of innovative vaccines against infectious diseases, in compliance with current GxP regulation. The incumbent of the position needs to support the company's vision and mission by acting with integrity, in a compliant, respectful, customer centered, accountable and compassionate way in order to support achieving the company's strategic goals. 

As a QP, you will be responsible for performing the legal and routine duties with respect to the review, approval and certification of licensed and investigational products. To maintain effective quality oversight of internal and external contract manufacturing and testing activities in order to verify that local and Global Quality Systems/procedures are defined, being adhered to, are operating effectively and comply with UK, EU, FDA, RoW regulatory requirements.

Your Responsibilties

• To perform the legal and routine duties of a QP with respect to the review, approval and certification of licensed and investigational products; as defined in article 51 of Directive 2001/83/EC (as amended by Directive 2004/27/EC) and described in Annex 16 of the EU Guide to GMP
• To represent the company to external authorities on liaison with MHRA, FDA, EMEA CAs and OMCLs on; product defect reporting, recall and Inspection related matters (all interactions must be aligned with Regulatory Affairs)
• To advise the Director of Quality Operations on any matters arising which impact on supplier or service provider status or the import of bulk product into EU, or release of final product for use in the UK/EU and its export from the EU
• To manage the batch disposition process, comprising batch document review and approval and batch certification file compilation. Make quality assessments on released products subject to temperature excursions and communicate to customers
• To ensure the systems and processes for the management of Product Technical Complaints and Product Recalls are being conducted in accordance with the licensed risk management and pharmacovigilance systems
• To act as Livingston site representative for Product Safety Review Board. Escalation of relevant issues to and from committee meetings/Global Quality Focus Groups
• To assist with the preparation, review and approval of technical / quality agreements for suppliers and service providers
• To prepare and / or review and approve Quality Investigations which impact on cGMP related activities and batch disposition decisions
• In compliance with UK, EU/FDA quality rules and guidelines, to manage the resources, procedures and reports necessary to ensure effective execution of the external supplier audit program to a defined schedule, in conjunction with Global Quality Assurance
• In conjunction with QA, to perform external audits and internal audits as deemed necessary (e.g. for-cause investigations and unscheduled cGMP audits). Provide support to management during third-party audits
• To independently verify the audit reports and programme compliance, escalate any adverse trends or major non-conformances reported and make recommendations on appropriate corrective action in support of the approval / rejection of suppliers or products
• To identify areas of improvement for internal and Global Quality Systems/procedures and to provide support with the implementation of such improvements
• In conjunction with the concerned departmental personnel, develop suitable reporting mechanisms (e.g. key quality indicators) which provide assurance of effective quality oversight of both internal and externally contracted manufacturing and testing activities
• To keep up to date with current guidelines and regulatory requirements (e.g. Pharmacopoeial changes) in respect of quality requirements
• Implement and maintain Standard Operating Procedures, as required
• To undertake any other duties as requested by the line manager in accordance with company requirements

Requirements

• Degree level education or equivalent experience
• Eligible QP (UK qualified, under the Permanent Provisions)
• Relevant experience of UK, EU and FDA cGMP requirements for the manufacturing and testing of biopharmaceutical products in a commercial environment
• Good understanding and working knowledge of the Pharmaceutical Industry

• Stock Options
• Employee Assistance Programme
• Gym membership OR fitness allowance
• LinkedIn Learning
• EV Salary Sacrifice scheme
• Many others included