Sr. Manager, Business Analyst

Sr. Manager, Business Analyst
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description


Business Analyst Sr. Manager

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual's contribution matters, and everyone has a chance to enhance their skills through ongoing 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 Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Job Overview

This role will represent the business on cross functional teams delivering several projects in Gilead's Commercial Manufacturing, Packaging and Labeling 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.

Job Responsibilities

• Supports business analysis for changes and new initiatives within the commercial manufacturing, packaging and labelling 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

Knowledge & Skills

• Pharmaceutical manufacturing, packaging and labeling operations knowledge including systems, business processes and controls
• 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
• 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 the 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 expertise of relevant US, EU and international pharmaceutical cGMPs / regulations
• Able to apply established organizational policies, and 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

Education & Experience

• 10+ years relevant experience in related field and a BS or BA; or
• 8+ years of relevant experience and a MA/MBA.

Experience in pharmaceutical operations/cGMP environment highly desirable.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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

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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 log onto your Internal Career Site to apply for this job.






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