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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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 world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s 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 we’re 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

Senior Quality Assurance Specialist will be responsible for approving key quality records including deviations, change controls and corrective/preventative actions (CAPA) at the La Verne site. This role will involve close collaboration with cross functional teams and subject matter experts (SMEs) to review and support impact assessments and risk evaluations. The Specialist will provide guidance to ensure that investigations, changes, and improvements are properly assessed for regulatory and operational impact, supporting a culture of continuous improvement and adherence to GMP requirements.

Responsibilities:

+ Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.

+ Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed, to ensure defined quality objectives are met.

+ Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).

+ Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.

+ Works closely with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications.

+ May participate in the writing contribution of annual product reviews and the development of training programs regarding all aspects of producing quality products.

+ May conduct or serve as a lead/coordinator/reviewer/approver for investigations, change controls, and corrective and preventive action (CAPA) recommendations related to manufactured products.

+ Works with Research and Development during new product start-ups and establishes key checkpoints for new products and processes.

+ May assist or lead compliance audits as required. May interface with regulatory agencies as required.

+ Interfaces with contract manufacturers to address documentation and compliance issues.

+ Mentor QA personnel, including organizing and prioritizing daily tasks, and performing training.

+ Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).

Basic Qualifications:

+ Doctorate OR

+ Master’s and 4+ years of relevant experience OR

+ Bachelor’s and 6+ years of relevant experience

Preferred Qualifications:

+ Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).

+ Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards.

+ Advanced understanding of international quality systems regulations to adopt best in class systems/processes.

+ Demonstrates the ability to effectively manage multiple projects/priorities.

+ Strong proficiency in QA systems and continuous improvement methodologies.

+ Proficient in QA principles, industry standards, and regulatory requirements.

+ Strong knowledge of GMPs and/or GLPs.

+ Ability to manage multiple projects and priorities effectively.

+ Strong analytical, conceptual, and problem-solving skills.

+ Excellent verbal communication, technical writing, and interpersonal skills.

+ Proficiency in Microsoft Office applications.

+ Familiarity with Six Sigma, DMAIC methodology, and quality improvement tools (preferred).

+ Working knowledge of risk management tools such as HACCP and FMEA (preferred).

The salary range for this position is: $123,930.00 - $160,380.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

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

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.