Business Analyst Manager (Sustainment)

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

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 to both internal sites and business functions and external secondary packaging CMOs & 3PLs.

Job Responsibilities

• Support 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 implement 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).

• Conduct 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

  • Conduct business impact assessments and analysis for serialization system upgrades and enhancements

  • Perform data driven analysis to determine impact on business process and functions

  • Develop business requirements and scenarios for technology assessment as required

  • Participate in cross functional business process mapping workshops/ sessions

  • 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

  • Lead the planning, coordinating and execution of User Acceptance Testing of new and upgraded system solutions and the associated impacted business processes

  • The scope of the analysis and related work will be across all sites, functions, alliance partners and CMO’s that support Gilead’s serialization related business processes (current or future)

• Represent Gilead’s 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)

• Assess the impact for any new product launches or packaging/ labelling changes, identify and manage completion of tasks to address any gaps

• Implement and maintain serialization systems, policies, processes and procedures ensuring compliance with regulatory requirements

• Serve as liaison between the company and the various governmental agencies and/or audit agencies as required

• Review, and/or implement changes to controlled documents as needed

• Work on problems of moderate complexity where analysis of situations or data requires an evaluation of intangible variables

Knowledge & Skills

• Pharmaceutical manufacturing and packaging 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, data integrity controls, and operational support methodologies

• 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

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

• Solid working knowledge and expertise of relevant US, EU and international pharmaceutical cGMPs / regulations

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

• Previous experience working as part of a large, multi-disciplinary team completing full project life-cycle implementations

• Ability to work in a team-oriented, collaborative environment

• Ability to be flexible and change activities quickly, based on business need

Education & Experience

• 6+ years relevant experience in related field and a BS or BA; or

• 4+ years of relevant experience and a MA/MBA.

• Experience in pharmaceutical operations/cGMP environment

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.

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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' poster.

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For Current Gilead Employees and Contractors:

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