Senior Quality Specialist - Combination Product Development

As a Development Quality professional, you will provide quality guidance and support across pharmaceutical, medical device and drug-device combination product development programmes, from early-stage development through clinical phases and into commercialisation. You will work as an active partner to development teams, helping ensure quality is designed into products and processes from the outset, while supporting scientific decision-making, regulatory compliance and successful product delivery.

Our Development Quality team works at the intersection of pharmaceutical science, device engineering and quality assurance. We partner closely with scientists, engineers, regulatory experts and manufacturing teams to ensure robust, compliant and risk-based development practices are embedded throughout the product lifecycle.

We believe quality is more than compliance. We help teams build quality into the product and process, apply sound scientific principles, manage risk proactively and generate the development knowledge needed to support regulatory approval, technology transfer and commercialisation.

• Provide Quality support and guidance to pharmaceutical, medical device and combination product development programmes from early development through clinical development and preparation for commercialisation.
• Support the application of ICH Q8 Pharmaceutical Development, Quality by Design (QbD) and Quality Risk Management principles.
• Partner with development teams to establish and maintain Quality Target Product Profiles (QTPPs), Critical Quality Attributes (CQAs), process parameters, risk assessments and control strategies.
• Apply appropriate GMP principles to development activities, clinical supply manufacture and testing programmes.
• Support medical device and combination product development in accordance with applicable Quality and regulatory requirements, including ISO 13485, EU MDR and FDA QMSR regulations.
• Provide oversight and support for design controls, design reviews, risk management, verification and validation activities.
• Collaborate with pharmaceutical scientists and device engineers to ensure effective integration of drug products and delivery devices.
• Develop, review and implement quality procedures, protocols and other supporting documentation.
• Review and provide oversight of deviations, investigations, change controls, CAPAs and other quality events.
• Support supplier and external partner quality activities, including Quality Technical Agreements and supplier quality management.
• Participate in and support internal and external quality audits, ensuring timely closure of findings.
• Help teams identify, assess and manage product, process and quality risks.
• Contribute to continuous improvement of quality systems, processes and ways of working.
• Promote a positive quality culture where quality is viewed as a collaborative partner in development.

You are a curious, collaborative and scientifically minded quality professional who enjoys working across functions and disciplines.

You understand that Development Quality is not simply about checking compliance after the fact. You see quality as an enabler of innovation and work alongside development teams to build quality into products and processes from the beginning.

You are equally comfortable engaging with pharmaceutical scientists on formulation or manufacturing challenges as you are discussing design controls, verification activities or risk management with device engineers.

Whether your background is stronger in pharmaceutical/GMP quality or medical device quality, you are excited by the opportunity to broaden your expertise across the full combination product…