Senior Quality Partner: Drug-Device Combo Development

Flint Hills Resources; Cambridge; Presencial; GBP 70.000 - 95.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Quality management

Regulatory compliance

Cross-functional collaboration

GMP knowledge

Risk management

Educación

Degree in Pharmaceutical Sciences, Engineering, Chemistry, Life Sciences

Descripción del empleo

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