Senior Manager, R&D Quality CPD
Role Overview
The role works with local and global R&D product development teams on Quality Management System compliance for combination products.
Quality support spans product concept, industrialization, and commercial lifecycle management.
The role has authority to review and approve project documentation in coordination with internal and external partners.
Key Skills for This Role
Full Job Posting
About Teva
Teva describes itself as a biopharmaceutical company with generics and innovative medicine businesses.
Role overview
The role works with local and global R&D product development teams on Quality Management System compliance for combination products.
Quality support spans product concept, industrialization, and commercial lifecycle management.
The role has authority to review and approve project documentation in coordination with internal and external partners.
Responsibilities
- Provide quality compliance guidance and review or approve project specifications, drawings, plans, protocols, reports, method validation, and change controls.
- Support QMS development and maintenance for design controls and ensure design control files are maintained.
- Address deviations, CAPAs, laboratory investigations, change controls, and other compliance matters with R&D partners.
- Resolve quality issues with R&D teams, contract laboratories, CMO partners, and CDO partners.
- Support design and technical transfers through protocol and report drafting, review, execution, and approval.
- Represent R&D Quality in design decisions, conduct internal and external audits, and report development status to management.
Required qualifications
- Degree in an appropriate scientific or engineering discipline; a higher degree is ideal but not essential.
- Significant medical device or combination product GMP experience and deep knowledge of applicable regulations.
- Experience with full-lifecycle R&D and design development of devices or combination products.
- Project experience in diverse teams and internal auditing experience.
- Well-developed organizational and communication skills.
Preferred skills
- Mechanical testing or automated equipment, injection molding or manufacturing, statistical models or methodology, multi-site project involvement, and ISO 13485 auditing are preferred but not essential.
- Leadership experience is described as ideal.
Role description note
The description identifies the position as Senior Quality Manager, Device R&D, while the supplied title is Senior Manager, R&D Quality CPD.
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