Unlike other roles with similar titles, our VP – Quality Assurance & Regulatory Affairs is truly a varied role, where you will influence the development of our business as we build a world-class CDMO.
This is a really exciting time to join us. We have ambitious plans to grow, and as we do our exposure to interesting customers and technology from across the inhaled therapy space will grow too.
About the role
As our VP of Quality & Regulatory Affairs (QA/RA), you’ll be responsible for providing strong leadership and guidance on global quality and regulatory affairs. Supporting both the established commercialised products and our customer’s new product introductions wherever they may be in the world.
You will be joining a strong team of quality and regulatory professionals, who you will lead through the next few years of growth and development.
This will be a diverse role where you will work with medical device products and a wide range of drug substances, including small and large molecule products, products already on the market, and those at earlier development stages too.
You and your team will provide quality and regulatory support for development and manufacturing for sponsor clinical trials, right through to commercialisation and release.
Key responsibilities include, but aren’t limited to:
• Leading the Quality & Regulatory Team in UK and Switzerland
• Providing strategic direction to the CEO and Executive Leadership Team; championing quality & regulatory intelligence
• Assuring regulatory requirements/standards are met and ensuring compliance across all sites
• Acting as the QA/RA leader with external parties such as Regulatory Agencies (MHRA, FDA, etc), Notified Body and customers
• Promoting both Quality and Regulatory capabilities with customers, to support Vectura CDMO business and revenue-generating opportunities
• Effective delivery to customers and partners on quality, regulatory, to plan, on budget, and on profit margin
What you’ll need
One of our key areas of focus moving forward will be meeting and adapting to different global QMS requirements and regulations for medical devices, drug, and combination products, to meet customer needs. As such we need someone who understands international standards and regulations. Inhalation experience would be desirable, but not essential.
As we have transitioned to being a CDMO we’re really interested in individuals with this experience, who can support our successful ongoing relationships with our customers.
We’re also looking for someone who can lead and influence. This role will act as an ambassador for Vectura, ensuring we provide solid quality and regulatory advice and guidance.
If you’re looking for a role where you can influence change for the greater good, further your own career and the careers of your team, then this could be the perfect role for you. We welcome applicants to apply today for more details.