"Alerted.org

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

This role will represent the business on cross functional teams delivering several projects in Gilead’s Commercial Manufacturing Organization. In this role, the individual will be responsible for ensuring initiatives and projects meet the core business requirements and impacted business processes are updated for internal manufacturing and serialization & traceability. These global business processes are applicable or used by internal sites, business functions, Commercial Manufacturing Organizations (CMOs), third party logistics (3PLs) providers, and alliance partners.

Responsibilities:

+ Supports business analysis for changes and new initiatives within the commercial manufacturing organization for internal manufacturing and global serialization & traceability enterprise systems

+ Responsible for documenting the as-is business processes and systems

+ Responsible for completion of high-level requirements gathering, use case development, and documentation of user requirements

+ Responsible for completion of business process re-engineering and change impact assessments

+ Manage the completion of system regression testing as required by Gilead’s IT validation processes

+ Planning, coordinating and execution of User Acceptance Testing of new and upgraded system solutions and the associated impacted business processes

+ Collaborates with Gilead’s global functional groups and supports the interpretation of both emerging and changing global serialization & traceability regulations and industry standards (e.g. GS1)

+ Determine impacts of these possible changes to Gilead systems and business processes and implementing solutions to support the new and changing regulatory and business requirements

+ Manage assigned global cross-functional strategies and activities associated with the implementation and management of activities for all commercial products across all manufacturing sites including all contract manufacturing organizations (CMOs).

+ Lead and perform strategic assessments based on business needs and requirements

+ Perform business process and enterprise systems assessments with IT and other business functions based

+ Develop solution options and cost analysis to meet business requirements

+ Develop and present results of strategic analysis to leadership

+ Represent Gilead’s Global Serialization & Traceability function on global cross functional teams and initiatives. Deliver robust system solutions to support Gilead’s serialization & traceability related business processes (current or future)

+ Works on problems of moderate to advanced complexity where analysis of situations or data requires an evaluation of intangible variables

+ Provides oversight, guidance and management of personnel working on assigned projects and operational support processes

+ Creates and maintains a positive working environment to ensure high productivity, employee engagement and performance.

+ Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results

+ Develops and implements strategies and goals for specific products or projects

+ Creates and effectively communicates supplier, subcontractor and/or vendor agreements and opportunities to the organization

+ May serve as liaison between the company and the various governmental agencies and/or audit agencies as required

+ Reviews, and/or implements changes to controlled documents as needed. May author sections of regulatory documents or position papers

Basic Qualifications:

+ BS/BS and 8+ years relevant experience in related field OR MA/MBA and 6+ years of relevant experience

+ Serialization and traceability expertise in a GMP environment including an in-depth understanding of SAP ATTP and the end-to-end serialization & aggregation business process from the packaging operations, warehousing, distribution and communication to both downstream trading partners and government systems.

+ Experience in pharmaceutical manufacturing, packaging and labeling operations knowledge including systems, business processes and controls.

Preferred Qualifications:

+ Demonstrates knowledge and proficiency across multiple practices within Supply Chain and Commercial Manufacturing departments, to understand, coordinate and communicate competing demands.

+ In-depth understanding and working knowledge of Software Development Lifecycle (SDLC) including basic knowledge of risk assessments, computerized systems validation processes and data integrity controls.

+ Able to develop solutions to a wide range of complex problems, which require regular use of ingenuity and innovation.

+ Exceptional verbal and written communication skills. Able to create written communication that is properly structured, providing clear, concise messages that draw well supported conclusions and recommendations.

+ Strong negotiation skills.

+ Good organizational and time management skills, including working knowledge of basic project management tools and techniques.

+ Ability to interact effectively with senior management.

+ In-depth understanding and application of relevant principles, concepts, practices, and standards, along with knowledge of industry practices and regulations.

+ Solid working knowledge and expertisein relevant US, EU and international pharmaceutical cGMPs / regulations.

+ Able to apply established organizational policies, interpret, execute, and recommend modifications to department policies and procedures as needed.

+ May require familiarity with the technologies, strengths, and weaknesses of a wide variety of secondary packaging capabilities and manufacturers worldwide.

+ Ability to collaborate cross-functionally.

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 receivingthe 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*.

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.