Sr Quality Engineer I

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.

Job Description

This opportunity is an exciting and challenging role that will be key to Gileads success as we work towards bringing new combination products such as pre-filled syringes and autoinjectors to market. As a Sr Quality Engineer I you will be a key Quality person who ensures compliant processes are in place to support the successful implementation and execution of Gileads combination product lifecycle management.

Key Responsibilities

• 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.

Basic Qualifications

• Bachelors degree in science or engineering-related field with at least 6 years of experience in the medical device industry OR Masters 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.

Preferred Qualifications

• 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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Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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