Senior Manager, R&D Quality CPD

The role of Senior 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: · Project design specifications · Drawings · Plans/protocols/reports related to design verification/validation · Method validation · Risk management activities · Change controls and more... 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 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 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.
  
  Degree in an appropriate scientific or engineering discipline.
• Ideally, Higher level (MSc/PhD) in the required scientific/engineering discipline, or pursuit of 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 regulations such as ISO 13485, 21 CFR Part 4/210/211, and 820.
• Full lifecycle R&D/design development of medical devices/combination products.
• Project experience as part of a diverse team.
• Auditing (internal) experience.
• Ideally bringing leadership experience.
• Well-developed organisational skills.
• Excellent communication skills.
Preferred skillset but not essential..
• Mechanical testing/automated equipment.
• Injection molding/manufacturing.
• Statistical models and methodology.
• Project involvement across multi-sites.
• ISO 13485 auditing.
  
  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.