Quality Manager, Device R&D

The role of Quality Manager, Device R&D works with local and global R&D product development teams to ensure compliance to the Quality Management System (QMS) for combination products delivery from concept through industrialization and commercial life cycle management. The position has review and approval authority on project documentation in coordination with internal and external business partners, including project design specifications, drawings, plans/protocols/reports related to design verification/validation, method validation, risk management activities, change controls, and more.

Responsibilities

• Define, develop and implement site / Global QMS GMP policies and procedures.
• Assure that project output meets combination product regulatory requirements.
• Assist in the development and implementation of site / Global QMS GMP policies and procedures.
• Ensure departmental compliance in generating and maintaining design control files (DHF's, DMR's).
• Provide quality compliance & guidance support for local/satellite R&D teams as required.
• Actively participate 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 business partners during events such as deviations, CAPAs, lab investigations, change controls.
• Work with R&D staff and business partners (e.g., contract laboratories, CMO's, CDO's) to solve complex quality issues affecting laboratory operations and device components/assembly.
• Provide quality support for design and/or technical transfer, including 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.
• If the position involves management of employees: actively manage a team of Quality Engineers and provide guidance on their work & development.

Qualifications

• Degree in an appropriate scientific or engineering discipline.
• Higher level (MSc/PhD) in the required scientific/engineering discipline, or pursuit of a higher level degree.
• Significant experience in the field of medical device/combination products GMP.
• Deep knowledge and expertise across relevant device regulations such as ISO13485, 21CFR Part 4/210/211, 820.
• Full lifecycle R&D/design development of medical devices/combination products.
• Project experience leading a diverse team.
• Internal auditing experience.
• Leadership experience (ideally).
• Well-developed organisational skills.
• Excellent communication skills.

Preferred Skills

• Mechanical testing/automated equipment.
• Injection molding/manufacturing.
• Statistical models and methodology.
• Project involvement across multi‐sites.
• ISO13485 auditing.

Benefits

At Teva, better health starts from within, and that includes you. From day one, you'll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (depending on role), access to tailored health support, and meaningful ways to give back to the community.

Career Development

When it comes to your career, you'll be encouraged to explore, evolve, and shape your path. Twist, our one‐stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short‐term projects to opportunities for internal growth. Here, you'll be part of a culture that empowers you to reach your goals and prioritise your wellbeing every step of the way.

Company Overview

We're Teva, a leading innovative biopharmaceutical company, enabled by a world‐class generics business. Whether it's innovating in the fields of neuroscience and immunology or delivering high‐quality medicine worldwide, we're dedicated to addressing patients' needs now and in the future. Here, you will be part of a high‐performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide together.