Manager, Manufacturing

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

Responsible for ownership execution and governance of Manufacturing risk assessments and change controls. This role provides leadership to ensure riskbased decision making compliant execution of changes and timely support of manufacturing operations while maintaining alignment with cGMP and regulatory expectations. The position collaborates closely with cross-functional partners and stakeholders to ensure risks are properly identified assessed mitigated and documented and manufacturing changes are effectively implemented without compromising product quality or supply.

RESPONSIBILITIES:

• Plans executes and tracks Manufacturing risk assessments and manufacturingdriven change controls in coordination with crossfunctional departments internally or externally.

• Provides focused ownership for Manufacturing risk assessment activities including creation updates and periodic reviews in alignment with approved methodologies and site procedures.

• Exercises judgment within generally welldefined procedures and practices to determine appropriate actions related to riskbased decisions and manufacturing changes.

• Normally receives no instruction on routine work and general instructions on new assignments.

• Oversees and contributes to the completion of technical and operational activities related to Manufacturing risk assessments and change controls through effective planning and prioritization.

• Manages complex processes across functions and interacts effectively with stakeholders to ensure regulatory requirements are met.

• Responsible for initiating and directing the implementation of Manufacturing changes across multiple projects and production areas including coordination of impact assessments and approvals.

• Tracks risk assessment and change control activities against established timelines and adjusts priorities based on changing Manufacturing and business needs.

• Directs issue resolution and supports crossfunctional alignment throughout the lifecycle of risk assessments and change controls.

• Supports development and maintenance of training materials related to Manufacturing risk assessments and change controls.

• Creates supports or reports performance metrics related to risk assessment and change control execution and contributes to continuous improvement.

KNOWLEDGE & SKILLS

• Demonstrates strong knowledge of Good Manufacturing Practices (GMPs) and working knowledge of applicable regulatory requirements and guidance documents.

• Demonstrates understanding of riskbased approaches within a Manufacturing environment.

• Is able to provide solutions to moderately complex to semiroutine problems.

• Demonstrates excellent verbal written and interpersonal communication skills.

• Demonstrates strong computer organizational and project management skills.

• Demonstrates ability to apply knowledge of current Good Manufacturing Practices (cGMPs) on a daily basis.

EDUCATION & EXPERIENCE

• 7 years of relevant experience with a BS or BA preferred.

• 5 years of relevant experience with an MS preferred.

• Prior experience in a cGMPrelated industry is required; biopharmaceutical or pharmaceutical manufacturing experience 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.

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.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.