Sr. R&D Quality Lead, Medical Devices

Teva Pharmaceuticals; Runcorn; On-site; GBP 80,000 - 110,000; Full time

Job summary

Teva Pharmaceuticals in the United Kingdom seeks a Senior Quality Manager, Device R&D to ensure QMS compliance for combination products from concept through industrialization and life-cycle management.

You will review and approve project documentation, lead design control files, support risk management, CAPAs and change controls, and collaborate with internal and external partners to maintain device regulatory readiness and device quality across global teams.

Qualifications

• Degree in an appropriate scientific or engineering discipline.
• MSc/PhD preferred for advanced expertise.

Responsibilities

• Provide quality compliance & guidance support for local/satellite R&D teams as required.
• Perform review and approval authority on project documentation in partnership with internal and external business partners to confirm that the output meets combination product regulatory requirements.
• Actively participates in the development/maintenance of the QMS in support of design control development of combination products & devices.
• Identify, recommend, communicate, and follow-up compliance and surveillance with R&D / laboratory partners in events such as deviations, CAPAs, lab investigations, change controls.
• Work with R&D staff and business partners (e.g. contract labs, CMOs, CDOs) in solving complex quality issues affecting laboratory operations and device components/assembly.
• Provide quality support for design and/or technical transfer including support in drafting, review, execution, and approval of protocols and reports.
• Manage and assure that necessary project development contact and Quality support is maintained with relevant business partners and Teva site teams.
• Represent R&D Quality in design decisions with business partners.
• Perform internal/external audits onsite and offsite as required.
• Communicate with management on device development status.

Skills

Quality management

Design control

Regulatory compliance

Auditing

ISO 13485

GMP

Project leadership

Cross-functional collaboration

Medical device knowledge

Education

Science/Engineering degree

MSc/PhD preferred

Job description

Teva Pharmaceuticals in the United Kingdom seeks a Senior Quality Manager, Device R&D to ensure QMS compliance for combination products from concept through industrialization and life-cycle management.

You will review and approve project documentation, lead design control files, support risk management, CAPAs and change controls, and collaborate with internal and external partners to maintain device regulatory readiness and device quality across global teams.