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Getting Hired

Assoc Director, Quality Assurance

Getting Hired, San Mateo, California, United States, 94409

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Overview

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 to develop therapies that help improve lives and ensure access to these therapies across the globe. We continue to fight 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 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 Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. This is a people leader role within the QA Packaging and Labeling team in Gilead's External Quality Operations department. The ideal candidate will have established people leader experience and some packaging/labeling experience. This is an onsite position based at our headquarters in Foster City, CA. Knowledge

Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards. Demonstrates excellent verbal, written and interpersonal communication skills. Experience as an effective people leader, driving high performance, developing talent, and resolving issues. Demonstrates some knowledge of Six Sigma tools, DMAIC methodology, performance measures and quality improvement approach. Demonstrates working knowledge of risk management tools such as HACCP and FMEA. Basic Qualifications

10+ years of relevant experience in a GMP environment related field and a Bachelors degree in science or related fields. OR 8+ years of relevant experience in a GMP environment related field and a Masters degree in science or related fields. Note:

All qualifications listed are the minimum requirements and may include equivalent experience. Specific Job Responsibilities

Manages QA personnel responsible for batch review and lot disposition activities, including organizing and prioritizing group tasks, performing training, and writing performance reviews. Performs activities to ensure compliance with regulatory requirements and current GMPs. Acts as an initial point of business escalation and provides guidance to staff on path-forward options. Participates in developing SOPs to ensure quality across internal and CMOs related to Packaging and Labeling. Ensures that product quality conforms to established standards and agency guidelines. Works with operating entities to ensure inspections, audits and statistical process control analyses are conducted on a continuing basis. Participates in compliance audits as required and interfaces with contract manufacturers to address performance or compliance issues. May interface with regulatory agencies as required. Writes and/or implements changes to controlled documents (e.g., SOPs, work instructions) as needed. Some positions may specialize in transferring and driving quality initiatives across CMO organizations (e.g., CMO technology transfer, CMO process improvement). People Leader Accountabilities

Create Inclusion - model inclusion and embed diversity value in team management. Develop Talent - understand skills, experience, aspirations and potential; coach for current performance and future potential. Empower Teams - align goals with organizational objectives and remove barriers to connect the team to the broader ecosystem. The salary range for this position is: $182,070.00 - $235,620.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. Eligible employees may participate in benefit plans, subject to plan terms. For more information about equal employment opportunity protections, please view the Know Your Rights poster. Gilead Sciences Inc. is an equal opportunity employer committed to fostering an inclusive work environment. Please apply via the Internal Career Opportunities portal in Workday if you are a current Gilead employee or contractor. #J-18808-Ljbffr