Sr IT Business Analysis Specialist (PDM Biologics Clinical Manufacturing)

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 DescriptionThe Sr IT Business Analysis Specialist (Tech Dev Biologics Clinical Manufacturing) in the PDM IT organization, will be a strategic technology partner to the PDM Biologics Clinical Manufacturing business capability, working with business colleagues to align technology direction with business goals and help define relevant and effective solutions while maturing existing systems and services in order to drive business value.The Sr Specialist will be responsible for the ideation, planning, development oversight for the Biologics Clinical Manufacturing business capability. Participates in short and long-term business or IT strategic planning sessions, identifying opportunities and making recommendations for the enablement of capabilities. Participates in the analysis efforts for business case development, including resource estimates, prioritization and categorization. Advises on options, risks, costs versus benefits, and impacts on end-user, processes and system priorities. Engages and collaborates with business leadership team members, senior business stakeholders and business process owners to cultivate technology solution aligning with business or IT strategies. Establishes and maintains a strategic relationship with leadership team members and senior business stakeholders.The role will be involved with IT solutions planning for PDM Digital Strategy initiatives through to successful execution of these initiatives. Projects may include web-based solutions (SaaS), specialized Tech Dev Biologics Clinical Manufacturing applications, extending enterprise technologies, and supporting IT Operations and Solution Delivery teams to enhance business effectiveness. Critical to the role will be championing projects and working with business teams to prioritize across initiatives. Also, works with Technical Development IT leadership in assisting in the management of the application portfolio. This role will direct both internal and a significant contingent of managed and contracted services staff to drive business outcomes.Essential Duties and Job FunctionsBusiness Knowledge/RelationshipCultivates and demonstrates a working knowledge of Biologics Clinical Manufacturing, Facilities & Engineering and Quality Control.Participates in short- and long-term strategic planning session to improve business or IT processes through capability developmentParticipates in discovery sessions to identify opportunities for improvements in business capabilities or IT operations and formulate proposals for cost-effective solutions based on engagement, project, and operations activitiesDemonstrates how capability enablement can assist selected departments / business areas and how platforms and solutions can support the achievement of short- and long-term business or IT capability goalsEstablishes and maintains a strategic relationship with select functional level stakeholders based on experience and contribution to business operationsParticipates in the development of business use cases, cost structure, and ROI model in support of investment projects and activities to build IT Roadmap and demonstrate clarity on how solution provides business valueStrategic Planning: Business roadmap alignment to product backlogActively communicates with select business capabilities, IT, vendors and other stakeholders, to ensure awareness of vision, roadmap, progress, risks, and results associated with a key capabilityWorks with appropriate business Subject Matter Experts (SMEs) and business stakeholders to proactively identify and evaluate risks associated with business decisions that may impact a capability enablementParticipates in workshop sessions for incremental roadmap assessments and business alignmentEducates and aligns business digital vision and needs with IT initiatives, beyond technical feasibilityIllustrates contextual insight to ensures IT development supports revenue growth, compliance, and customer outcomesPresents Voice of the Business by capturing evolving business needs and translates them into system capability targetsStrategic Planning: IT System Roadmap IntegrationParticipates in workshop sessions for Strategic Planning to connect business objectives to long-term IT capabilitiesProvides input to anticipates changes in scale, market, or regulation to future proof and incorporate them into the roadmapParticipates in cross-functional teams to align product, operations, and IT on a single directionTechnical Implementation: Business requirements alignment to optimized business processesProvides input to Business Translation Layer to ensure delivery solves business problems to enable DevOps team for code deliveryReduces rework by validating business requirements upfront, avoiding costly misalignment during implementationEnhances change management with increased adoption by ensuring workflows and training match the business contextWorks with business process owners and DevOps leads to cultivate appropriate solution required to meet business or IT objectivesEngages Domain Architecture team to align long-term technology strategy with business objectivesSets proper expectations with business and supports escalation and resolution through negotiation or governance mechanismsParticipates in analysis of current and future technology trends to determine impact to the business, provides input to IT team lead to promote capability enablement and benefit realizationCommunicates to other IT domains for awareness of key capability aspects, how they operate and how they are impactedOperational Support: Change management and continuous value realizationParticipates in tracking business KPIs post-implementationProvides feedback loops for product enhancements and roadmap updatesProvides input to ensure IT delivery remains aligned with evolving business needsLeadership & ManagementProvides input to IT team lead to help prioritize the flow of work in program backlogFosters a team environment and shares relevant information with IT team membersExperience & Skills:Strong communication, excellent research skills, and learning agility to understand internal business or IT process, best practices and translate into technology needs/opportunitiesStrong collaboration, stakeholder management and communication skills – including verbal, written, and negotiationStrong Listener. Be able to patiently listen to understand the business needsStrong work ethic, a sense of business urgency, and the ability to work effectively with many deadlines in a complex matrix organizationProven track record of critical thinking, analytical ability, operational excellence, and detail orientation.Possesses ability to analyze make critical decisions based on analysisAbility to find innovative ways to resolve problemsExperience in stakeholder management, dealing with middle management up to executive levelSpecific experience in the Life Sciences/Pharma/Medical Devices/Healthcare industries is preferredDemonstrated expertise in technology environments relevant to Biotech Clinical Manufacturing productionExperience with platforms critical to Biologics Clinical Manufacturing (e.g., MES / Electronic Batch Records, ERP Mfg, CMMS, Digital Process and Automation, Historian, IOT, etc. ) and a willingness to learn and adapt to new Biologics Clinical Manufacturing IT systems as they emergeExtensive knowledge of Agile methodologies and tools (e.g. Jira, Asana, etc.), with proven abilities to apply these in supporting IT solutions that meet both business needs and clinical manufacturing objectives.Experience in programming environments (e.g., Python, R) and cloud computing platforms (e.g., AWS), especially those relevant to data and analytics in life sciences is very desirableAwareness of emerging IT trends and technologies (e.g. GenAI, Digital Twin, Process Analytical Technology, AI/ML Predictive Analytics, etc.), with a commitment to continuous learning, especially in areas relevant to biopharmaceutical research.Basic Qualifications:Bachelor's degree and 5+ years of relevant experience; ORMasters' degree and 3+ years of relevant experienceDegree in computer science, information sciences or related field or equivalent experience. Preferred Qualifications:Strong understanding of GxP compliance and 21 CFR Part 11 requirements.Significant IT experience in a corporate or other relevant business environment, with a strong preference for experience in the biopharmaceutical industry.Experience with IT implementations, integrations, cloud transformations, and understanding of data security and compliance issues in a scientific or healthcare setting.Knowledge of Biologics Clinical Manufacturing processesHighly organized, results-oriented and attentive to details, self-motivated, proactive, independent and responsive - requires little supervisory attentionGood understanding of GxP compliance and 21 CFR Part 11 requirementsExperience with Biologics Clinical Manufacturing is preferredMust be quality oriented and ensure all work streams are aligned with business, IT compliance, and cGMP regulationAbility to translate technical topics into business termsPeople 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 receiving the 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: $126,820.00 - $164,120.00. 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.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 View email address on click.appcast.io for assistance.For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTGilead 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.SummaryLocation: United States - California - Foster CityType: Full time