Director Quality Operations

This job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board. 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.

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. This role is 'hands on' and will interact with diverse relationships (internal / external) across all functions required to routinely ensure / oversee quality in the manufacture / supply of the commercial vaccines and the manufacture of vaccines/materials used in clinical trials.

To ensure that all operations on site are being conducted according to all internal and external quality and regulatory compliance requirements by leading and managing an integrated quality function (i.e. QA Operations, Validation and Quality Systems, QC and Regulatory Compliance & Risk Management) as well as acting as the local contact for the oversight and coordination of Regulatory Affairs activities related to Livingston site licensing, product licenses and registered processes. To act as a UK Qualified Person on the UK MIA(H) and MIA(IMP) licenses and as Responsible Person for Importation (RPi) on the UK WDA(H) license, as required by the company. To support the RPis, the RPs and other QPs on the site by acting as the Lead QP.

Requirements

• Site functional lead for Quality and compliance with applicable pharmaceutical regulatory requirements;
• Local line management responsibilities for Quality Assurance and Quality Control.
• Recruit, lead and develop local site Quality teams.
• Budgetary control for the function at the site.
• Quality and GMDP/GCLP oversight of the site, including the performance of CMOs, Suppliers, Consultants and service providers.
• Responsible for the local QMS and implementation of (and adherence to) the Global QMS.
• Ensure the site is ready for GMDP inspection at all times.
• Ensure Regulatory Compliance by supporting the Regulatory Affairs department where appropriate and ensuring that all licensing conditions, regulatory authority guidance and expectations are respected.
• Assist in setting Valneva's GxP quality standards, as part of the Global Quality Leadership Team.
• Lead the site's Quality escalation to senior management (primarily the Site Head and the Vice President Global Quality).
• Provide Quality, GxP and regulatory compliance guidance/advice at site level.
• Develop, collate and report key quality metrics and use these to drive a culture of continuous process improvement and compliance.
• Chair the Quality Review Board (QRB) for the site.
• Represent Site Quality in the Site Executive Team.
• Represent Site Quality in the Global Quality Leadership Team, and in global governance bodies such as Global Quality Management Review board.

Experience

• Bachelor's degree in the Life Sciences, with not less than 8-10 years' work experience in the lifescience or pharmaceutical industry, ideally including vaccines.
• A Master's degree (or higher) is preferable.
• Extensive (a minimum of 5 years') senior management experience within Quality Assurance, Quality Systems and Quality Control in GxP regulated lifescience or pharmaceutical industry.
• Experience as a QP / RP in EU and the UK is desirable.
• Eligibility to become an RP and/or QP is a requirement.
• Experience from hosting UK MHRA and other global regulatory authority inspections.
• Profound knowledge of relevant GxP (GMP, GDP, GCP, GCLP) legislation for the UK, EU, US and other global highly-regulated markets.
• Accustomed to work in an international environment with multilingual teams composed of various cultures is desirable.

Required skills

• Strong management and leadership skills with the ability to motivate and engage.
• High standards of professional / healthcare ethics and integrity with an extensive knowledge of all applicable quality and regulatory related standards, regulations and internal procedures.
• Open-minded and innovative / creative team-player.
• Good interpersonal communication and influencing / assertiveness skills.
• Able to work cross-functionally with Pharmacovigilance, Manufacturing, Process Development, IT, HR, Engineering, Regulatory Affairs, Supply Chain, MSAT and Finance.
• Proactive, solution-oriented and able to react flexibly in a fast-changing environment.
• Able to make timely, correct and compliant decisions that, as applicable, are aligned with business needs.
• Ability to analyse information in a structured, rational and scientific / balanced way.
• Ability to manage and prioritise the workload both for the site Quality & Compliance function as well as on a personal level.
• Excellent English (a working knowledge of additional global languages would be an asset).

Benefits

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