Senior Manager, Quality Assurance

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

AtGileadour pursuit of a healthier world for all people has yielded a cure for hepatitis C revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the worlds most devastating diseases united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to aSenior Manager Quality Assurance at Gilead you will report to the Associate Director Quality Assurance within the PDM External Quality organization. This position is dedicated to managing and supporting the Gilead Global Quality Agreement Program.

This position will have high visibility throughout the PDM organization as the Global Process Owner (GPO) for Gileads Global Quality Agreement Program and will collaborate with key internal partners & stakeholders to establish and maintain an effective Global Quality Agreement Program. This position will serve as the primary subject matter expert (SME) for matters related to Quality Agreement content Quality Agreement lifecycle management Quality Agreement negotiations management of Quality Agreement templates in compliance with applicable laws and regulatory requirements and supporting continuous improvement initiatives related to the Global Quality Agreement Program.

Job Responsibilities

• Serves as the Global Process Owner (GPO) for Gileads Global Quality Agreement Program ensuring the program is compliant consistent and effectively implemented across the organization

• Develops maintains and continuously improves standardized Quality Agreement templates guidance documents training materials and related tools to align with global regulatory requirements and internal policies

• Serves as the primary subject matter expert (SME) for Quality Agreement content interpretation and applicability across internal teams and external partners which may include supporting internal stakeholders during review negotiation implementation enforcement and periodic review of Quality Agreements.

• Drives alignment and resolution of complex Quality Agreement terms through collaboration with Legal Sourcing and External Quality stakeholders

• Establishes and maintains governance processes metrics and reporting for the Global Quality Agreement Program to ensure transparency and effectiveness

• Monitors regulatory trends and evolving expectations related to Quality Agreements and proactively updates program requirements and templates accordingly

• Provides expert support during inspections and audits related to Quality Agreements including preparation defense and remediation activities

• Leads or contributes to continuous improvement initiatives to enhance Quality Agreement processes reduce cycle times and improve compliance and user experience

• Supports training and knowledge-sharing activities to ensure consistent understanding and application of Quality Agreement requirements across the organization

The best candidate...

• Demonstrates expertise in Quality Agreements including development negotiation lifecycle management and governance in a global GMP environment

• Demonstrates strong working knowledge of global regulatory requirements applicable to Quality Agreements (e.g. FDA EMA ICH) and ability to translate requirements into compliant contract content

• Demonstrates strong technical writing skills with the ability to draft review and standardize Quality Agreement templates and supporting documentation

• Demonstrates advanced stakeholder management influencing and negotiation skills across cross-functional and external partner environments

• Demonstrates ability to manage and support complex high-visibility programs with multiple concurrent deliverables and competing priorities

• Demonstrates strong communication skills including the ability to clearly articulate Quality Agreement expectations to internal stakeholders and external partners

• Demonstrates the ability to learn quickly and operate effectively in a fast-paced highly regulated environment

Requirements

• 8 years of relevant experience in a GMP environment related field and a BS or BA OR

• 6 years of relevant experience in a GMP environment related field and a MA/MS OR

• 2 years of relevant experience in a GMP environment related field and a PhD/PharmD

Preferred Knowledge

• Experience working with and managing relationships with Contract Manufacturing Organizations (CMOs) and other external partners is preferred

• Experience interacting with regulatory authorities and supporting inspections related to Quality Agreements or external quality oversight is beneficial and preferred

• Experience managing global programs or serving as a Global Process Owner (GPO) is beneficial

• Familiarity with digital tools or systems supporting document management contract lifecycle management or Quality Agreement tracking is beneficial

• Experience and working knowledge with digital Quality Management Systems and Quality Document Management Systems particularly Veeva Vault is beneficial..

People Leader Accountabilities

• Create Inclusion -knowingthe 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 employeesare receivingthe feedback and insight needed to growdevelopand realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals purpose and organizationalobjectives 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: $157590.00 - $203940.00. 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:

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 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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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.