Senior Manager, R&D Quality Business Partner
1 day ago
Gilead Sciences is seeking a highly skilled and experienced Quality Business Partner to join our R&D team. As a Quality Business Partner, you will play a critical role in ensuring the quality and compliance of our products and processes.
Key Responsibilities- Act as the R&D Quality Business Partner to assigned groups, providing strategic, expert advice and consultation on R&D quality, risk, and continuous improvement.
- Provide education and training to assigned groups on Gilead quality policy and procedural standards, GxP regulations, and other requirements.
- Lead and participate in Quality forums, cross-functional teams, and projects, ensuring the implementation of quality standards and best practices.
- Collaborate with other R&D Quality groups to ensure just-in-time support and resources to assigned groups, including data, reporting, training, audit, inspection, risk assessment, and deviation/CAPA management support.
- Represent Gilead in regulatory inspections and play a lead role in R&D vendor qualification, on-boarding, relationship management, and governance.
- PharmD/PhD with 0+ years' experience, or MA/MS/MBA with 6+ years' relevant experience, or BA/BS with 8+ years' relevant experience.
- Significant experience working with GxP processes and systems in the biopharma or related industry is strongly preferred.
- Experience working with total quality management methodologies, such as Lean Six Sigma, is preferred.
- Experience working with one or more Gilead therapeutic areas and varying stages of drug development is a plus.
Gilead Sciences offers a competitive salary range of $154,000 to $199,000, depending on experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package, including company-sponsored medical, dental, vision, and life insurance plans.
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