Senior Manager, Quality – Combination Products, Compliance
Gilead Sciences(5 months ago)
About this role
This role is a Quality leadership position at Gilead’s La Verne site focused on ensuring compliance and robust quality system support for medical device/combination products such as vial kits and pre-filled syringes. The position partners broadly across functions and engages with external standards and regulatory expectations to help bring new combination products to market. It may also include people leadership responsibilities.
Required Skills
- Quality Management Systems
- Combination Products
- Medical Devices
- Regulatory Compliance
- ISO 13485
- 21 CFR 820
- ISO 14971
- IEC 62366
- Process Mapping
- SOP Development
+14 more
Qualifications
- Master’s Degree (Science or Engineering)
- Bachelor’s Degree (Science or Engineering)
- ASQ Certification (CQA, CQE, or CQM)
About Gilead Sciences
gilead.comGilead Sciences is a biopharmaceutical company dedicated to transforming patient care by advancing therapeutics in areas like HIV, liver disease, cancer, and inflammation. With a strong commitment to innovation, Gilead leads in the research and development of new medicines, aiming to make the world a healthier place. Their portfolio includes breakthrough therapies and ongoing advancements across multiple therapeutic areas, supported by a robust pipeline of clinical trials. Gilead is recognized for its contributions to public health and its efforts to improve access to vital medications.
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