Sr Specialist, Quality Systems

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

Senior Quality Assurance Specialist willbe responsible forapproving key quality records includingdeviations change controls and corrective/preventative actions (CAPA)at the La Verne site. Thisrole will involve close collaboration with cross functionalteams andsubject matter experts (SMEs) to review and support impact assessmentsand risk Specialist will provide guidance to ensure that investigations changes and improvements areproperly assessedfor 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 qualityobjectivesand regulatory requirements.

• Participates in writing or suggesting changes to controlled documents (e.g. SOPs Specifications Methods etc.) as needed to ensuredefined qualityobjectivesare 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 controlanalysesand audits are conducted on a continuing basis to enforce requirements and meet specifications.

• Mayparticipatein thewritingcontributionof annual product reviews and the development of training programsregardingall aspects of producing quality products.

• Mayconduct orserve as a lead/coordinator/reviewer/approverforinvestigations change controlsand corrective and preventive action (CAPA)recommendationsrelated to manufactured products.

• Works with Research and Development during new productstart-ups andestablisheskey checkpoints for new products and processes.

• Mayassistor lead compliance audits asrequired. May interface with regulatory agencies asrequired.

• 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
• Masters and 4 years of relevant experience OR
• Bachelors and 6 years of relevant experience

Preferred Qualifications:

• Demonstratesproficiencyin Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).

• Demonstratesproficiencyinapplicationof QA systems principles concepts industry practices and standards.

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

• Demonstratestheability to effectively manage multiple projects/priorities.

• Strongproficiencyin 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.

• Proficiencyin Microsoft Office applications.

• Familiarity with Six Sigma DMAICmethodology and quality improvement tools (preferred).

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

For additional benefits information visit:

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 disabilitygenetic 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 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 for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

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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.