Valneva is a specialty vaccine company focused on prevention against diseases with major unmet needs. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has various vaccines in development including unique vaccines against Lyme disease, chikungunya and COVID-19. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with over 500 employees.
An opportunity has arisen in Quality Operations for a Qualified Person (QP). This is a new, full-time, permanent role reporting the Director of Quality Operations/QP.
Job Summary: Performing 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, adhered to, and are operating effectively within UK, EU, FDA, RoW regulatory requirements and standards.
Ideal Candidate: Qualified under permanent provisions, preferably with biological products experience. A biology qualification or equivalent with a minimum of sterile dosage form manufacturing and release experience. Experience in a vaccine production environment would be a strong advantage.
- 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 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 with an impact on supplier or service provider status, 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 subjected 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 cGMP-related activities and batch disposition decisions
- 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 and in compliance with UK, EU and FDA quality rules and guidelines,
- To perform external audits and internal audits as deemed necessary (e.g., for-cause investigations and unscheduled cGMP audits), in conjunction with QA. Provide support to management during third-party audits
- To independently verify 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
- To 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, in conjunction with the concerned departmental personnel,
- To keep up to date with current guidelines and regulatory requirements (e.g., Pharmacopoeial changes) in respect of quality requirements
- To implement and maintain Standard Operating Procedures, as required
- To undertake any other duties as requested by the line manager in accordance with company requirements
- Qualified Person under permanent provisions
- Sterile dosage form experience
- Experienced in batch manufacturing and release
- Ability to manage conflicting priorities and workloads
- Ability to work well on own initiative and under pressure, be able to think ‘outside the box’ well as being able to work well with others
- Biology degree or equivalent
- Biological product/vaccine experience would be an advantage
- Previously named on a Manufacturing Importing Authorisation (MIA)
Skills and Competencies:
- Proven ability to make confident decisions based upon sound justification
- Proven ability to apply problem solving skills to a wide range of issues while maintaining a positive attitude towards those involved
- Proven ability to manage multiple tasks simultaneously whilst maintaining a high level of accuracy in all work carried out
- Demonstrable ability to adapt to change and implement change accordingly