Senior Quality Specialist - Combination Product Development

Flint Hills Resources; Cambridge; Sur place; GBP 70 000 - 95 000; Plein temps

Résumé du poste

Phillips Medisize, a Molex company, seeks a Senior Quality Specialist to guide quality across pharmaceutical, medical device, and combination product development from early stages through to commercialisation. You will partner with cross-functional teams to embed Quality by Design and risk management into development activities.

You will apply GMP, ISO 13485, EU MDR, and FDA QMSR frameworks, overseeing design controls, deviations, CAPAs, audits and supplier quality efforts while driving a

Qualifications

• Degree qualification (or equivalent) in Pharmaceutical Sciences, Engineering, Chemistry, Life Sciences or related discipline.
• Experience in regulated pharmaceutical, medical device or combination product environments.
• Strong knowledge of GMP, ICH Q8, Quality by Design (QbD) and Quality Risk Management principles.

Responsabilités

• Provide Quality guidance across pharmaceutical, medical device and combination product development programmes from early development through clinical development and preparation for commercialisation.
• Support application of ICH Q8, QbD and Quality Risk Management principles.
• Partner with development teams to establish and maintain QTPPs, CQAs, process parameters, risk assessments and control strategies.
• Apply GMP principles to development activities, clinical supply manufacture and testing programmes.
• Support medical device and combination product development per ISO 13485, EU MDR and FDA QMSR requirements.
• Provide oversight for design controls, design reviews, risk management, verification and validation activities.
• Collaborate with scientists and engineers to integrate drug products and delivery devices.
• Develop, review and implement quality procedures and documentation.
• Review deviations, investigations, CAPAs and change controls and ensure timely closure.

Connaissances

Quality management

Regulatory compliance

Cross-functional collaboration

GMP knowledge

Risk management

Formation

Degree in Pharmaceutical Sciences, Engineering, Chemistry, Life Sciences

Description du poste

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 Team

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.

What You Will Do

• 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.

Who You Are

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 development lifecycle.

What Will Put You Ahead

• Degree qualification (or equivalent experience) in Pharmaceutical Sciences, Engineering, Chemistry, Life Sciences or a related discipline.
• Experience working within a regulated pharmaceutical, medical device or combination product environment.
• Strong understanding of GMP, pharmaceutical development, ICH Q8, Quality by Design (QbD) and Quality Risk Management principles.
• Knowledge of medical device design controls, risk management, verification and validation activities.
• Familiarity with ISO 13485, EU MDR and FDA Quality Management System Regulation (QMSR) requirements.
• Experience working with deviations, investigations, CAPAs and change control systems.
• Experience supporting supplier quality management and external development or manufacturing partners.
• Experience participating in internal or external quality audits.
• Strong communication and influencing skills, with the ability to build effective relationships across scientific, engineering, regulatory and quality teams.
• A pragmatic, proportionate and risk-based approach to quality, combined with the confidence to challenge constructively and support practical solutions.
• Experience with drug-device combination products, inhalation technologies, pharmaceutical formulation or process development, clinical supply manufacture, technology transfer or commercialisation activities would be particularly valuable.

What will really set you apart is a passion for integrating pharmaceutical and device quality disciplines, a collaborative mindset, and a commitment to helping teams deliver high-quality products that improve patients' lives.

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

Who We Are

Phillips Medisize, a Molex company, collaborates with industry leaders to design and manufacture drug delivery systems, medical devices and diagnostic tools that save and improve the quality of life for millions of patients annually. With our dedicated team of 6,000+ employees in 29 locations around the world, we share our customers’ mindset that every product is critical to a healthcare provider and their patients somewhere in the world. Molex is a multi-sector global electronics brand owned by Koch, Inc., one of the world’s largest privately held companies. Discover your potential to make a difference.

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.