Sr Manager, Quality Systems

Quality Assurance Role

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.

Quality Assurance delivers on Gilead's commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies.

As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.

You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining QA within PDM, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Key Responsibilities

Supports, facilitates and adapts the Gilead Quality Management System related to computerized system lifecycle management to ensure that it meets regulatory and industry standards and expectations.

Identifies and onboards qualified external resources to support project demand.

Provides expert guidance on topics related to computer system compliance to regulatory requirements.

Identifies opportunities for, and leads implementation of projects that drive the continued improvement of Gilead's quality management processes related to management of computerized systems.

Ensures that technical, business and QA teams are prepared for regulatory inspections related to computerized systems

Provide oversight and QA approvals for GxP Deviations, CAPAs and change controls to ensure activities are conducted in compliance with Gilead procedures and regulatory requirements.

Authors or approves procedures, work instructions and other governing documents to support Gilead's computerized system lifecycle

Reviews and approves validation deliverables for medium-to large-sized projects.

Essential Functions

Performs a wide variety of activities to ensure compliance with GxP Laboratory systems, quality procedures and applicable regulatory requirements.

Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.

Basic Qualifications

Bachelor's degree and 8+ years of relevant experience; OR Masters' degree and 6+ years of relevant experience; OR PhD and 2+ years of relevant experience

Preferred Qualifications

Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs).

Demonstrates in-depth knowledge of QA systems principles, concepts, industry practices, and standards.

Demonstrates excellent verbal, written, and interpersonal communication skills.

Keen understanding of international quality systems regulations to adopt best in class systems / processes and drive continuous improvement initiatives.

Demonstrates knowledge of Information Systems Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements.

Expert knowledge of regulatory requirements pertaining to computerized systems in GxP environments.

Experience applying risk management principles to computer system validation and qualification activities.

Thorough understanding of Data Integrity concepts and controls for Laboratory computerized systems.

Ability to evaluate Quality Systems and drive value added enhancements.

Strong interpersonal and collaboration skills; must be able to positively influence employees who are working with the normal chain of command in order to achieve results.

Experience interfacing with regulatory authorities to present company methodologies and deliverables during inspections.

Ability to author and critically review SOPs.

People Leader Accountabilities

Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The salary range for this position is : $157,590.00 - $203,940.00. 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.

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

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 ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE : EMPLOYEE POLYGRAPH PROTECTION ACT 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.

Please apply via the Internal Career Opportunities portal in Workday.