Quality Manager, Device R&D in Runcorn

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 will have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

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. This includes, but is not limited to:

• Drawings
• Plans/protocols/reports related to design verification/validation
• Method validation
• Change controls

The role assures that project output meets combination product regulatory requirements. This position assists in the development and implementation of site / Global QMS GMP policies and procedures. Additional responsibilities will ensure departmental compliance in generating and maintaining design control files (DHF’s, DMR’s).

Essential duties and 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 business partners and external business partners (product design specifications, drawings, plans/protocols/reports related to design verification/validation, method validation, change controls and other documentation) to confirm that the output meets combination product regulatory requirements.
• 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 in 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) 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.

If the position involves management of employees: the manager will actively manage a team of Quality Engineers and provide guidance on their work & development.

Your Skills and Experience:

• Degree in an appropriate scientific or engineering discipline.
• Ideally, Higher level (MSc/PhD) in the required scientific/engineering discipline, or pursuant to or achievement of a higher level degree.
• Significant experience in the field of medical device/combination products GMP.
• Deep knowledge and expertise across relevant device regulatory such as ISO13485, 21CFR Part 4/210/211 820.
• Full lifecycle R&D/design development of medical devices/combination products.
• Project experience of a diverse team.
• Auditing (internal) experience.
• Ideally bringing leadership experience.
• Well-developed organisational skills.

Preferred skillset but not essential:

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

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 (dependent on role), access to tailored health support, and meaningful ways to give back to the community. 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.

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.