Gilead Sciences, Inc.
* Develop key relationships and interface extensively with internal stakeholders to address and resolve quality and compliance issues related to drug-device combination products.* Identify gaps in existing processes and lead cross-functional teams to develop and implement solutions.* Write and/or implement changes to controlled documents (e.g., SOPs, Specifications, Work Instructions).* Work with management and department personnel to achieve goals and strategic initiatives.* Identify, plan, and execute changes to quality processes to ensure conformance and continuous improvement.* Ensure changes to commercial products comply with FDA QSR/QMSR, ISO 13485, and other applicable standards.* Maintain compliance with global Risk Management processes in accordance with ISO 14971 and other applicable standards.* Collaborate with SMEs from R&D, Clinical, and Operations to ensure comprehensive application of risk processes.* Participate in annual product reviews and periodic updates of DHF and RMF.* Maintain expertise in current and emerging requirements and quality trends for Pharmaceuticals, Medical Devices, and Combination Products worldwide.* Support due diligence and internal/external audits or inspections as needed.* Assist with complaint investigations and communicate findings to design, development teams, and CMOs.* Stay abreast of evolving regulatory requirements to ensure compliance of commercial products.* May support design and development activities as required.* Bachelor’s degree in science or engineering-related field with at least 6 years of experience in the medical device industry, OR Master’s degree with at least 4 years of relevant experience.* In-depth knowledge of Quality principles, concepts, industry practices, and standards.* Quality experience in both clinical and commercial products.* Strong understanding of U.S. and international quality systems regulations/standards.* Ability to work independently and in a global team environment.* Excellent interpersonal and communication skills.* Previous experience with combination devices (e.g., autoinjectors, pre-filled syringes).* Well-versed in risk management methodologies and tools (e.g., Hazard Analysis, FMEA).* Knowledge of ISO 14971 Risk Management processes.* ASQ certifications (Certified Quality Auditor, Certified Quality Engineer, Certified Quality Manager) or equivalent.* Familiarity with emerging regulatory requirements and ability to drive continuous improvement initiatives.
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