Capability Manager, Global Track and Trace & PDM Data Stewardship/Management

Location
Raleigh, NC, United States
Posted
Jun 10, 2021
Ref
2295467
Required Education
Bachelors Degree
Position Type
Full time

Capability Manager, Global Track and Trace & PDM Data Stewardship/Management
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

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 pursuing scientific invention to prevent and treat life-threatening
diseases, including HIV, viral hepatitis and cancer. Gilead has operations in more than 35 countries
worldwide, with headquarters in Foster City, California.

You will be part of a team that is helping millions of people live healthier, more fulfilling lives. We are
a close community where every individual matters and everyone has a chance to enhance their skills
through ongoing development. Inclusion is one of our core values, which means we are creating and
fostering a work environment where our differences are valued, and everyone feels respected and
empowered to bring their authentic selves to work. By joining Gilead, you will further our mission to
discover, develop and deliver innovative therapeutics for people with life-threatening diseases.

Specific Responsibilities and Skills

The R&D / PDM group within IT department is responsible for working with functional business partners in the design, build, deployment, and support of business applications globally. The Capability manager in conjunction with DevOps Lead and Global capability lead work together to deliver against set business objectives and have measured outcomes- typically leading the applications-related business and technology workstreams. R&D / PDM group also works closely with other cross-functional groups within IT namely Security, Worldwide Infrastructure Operations, and Enterprise Platform teams in the delivery of these capabilities leveraging Systems Life cycle (SLC) methodologies. The PDM Capability Manager will be responsible for business capabilities in the areas related to Pharmaceutical Development and Manufacturing areas - Global Serialization and Traceability domain. The Capability Manager will support the development of the business vision and capability map for the PDM business. This individual works with the business on its strategic requirements and is responsible for the delivery and sustainment of the end to end customer experience. This role specifically requires strong management and leadership experience to work with capability managers and functional business partners in the design, deployment, and support of business applications supporting the Regulatory space within the Development Organization. The capability manager is responsible for the ideation, planning, development oversight of one or more business or information technology capabilities. Participates in short and long-term business or IT strategic planning sessions, identifying opportunities, and making recommendations for the enablement of capabilities. Leads 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. Collaborates with functional stakeholders and technical resources to cultivate technology solutions aligned with business or IT strategies. Establishes and maintains a strategic relationship with functional level stakeholders.

Essential Duties and Job Functions

General responsibilities for this position will include (but are not limited to) the following:

Business Knowledge/Relationship

 

  • Cultivates and demonstrates an in-depth knowledge of a global track and trace and data stewardship
  • Participates in short- and long-term strategic planning session to improve business or IT processes through capability development
  • Analyzes business or IT operations to understand their strengths and weaknesses to determine opportunities for improvements through capability enablement
  • Demonstrates how capability enablement can assist departments/business areas and how platforms and solutions can support the achievement of short- and long-term business or IT capability goals
  • Establishes and maintains a strategic relationship with functional level stakeholders
  • Development of use cases, cost structure, and ROI model in support of investment projects and activities demonstrating clarity on how the solution provides business value
  • Lead feasibility analysis and assessments for new regulatory requirements, including understanding implications for the current and future functional global track and trace as well as data stewardship architecture and selection of new systems/applications if required.
  • Subject matter expert on global track and trace, primarily responsible for gathering functional/business requirements for solution design for packaging and warehouse operations complying with US FDA (DSCSA), South Korea, China, Brazil, EU and other markets serialization requirements as global regulatory requirements continue to evolve.
  • Actively communicates with business, IT and other stakeholders, to ensure awareness of vision, roadmap, progress, risks, and results associated with a key capability
  • Works with appropriate stakeholders to proactively identify and evaluate risks associated with business decisions that may impact a capability enablement
  • Participates in incremental planning and defines release intervals
  • Works with functional stakeholders and technical resources to cultivate appropriate solution required to meet business or IT objectives
  • Confirms the business or IT need is addressed by the technical solution from a capability point of view
  • Ensures capability expectations are set and identifies and resolves disconnects through negotiation or governance mechanisms
  • Analyzes technology trends to determine impact to the capability and benefit realization
  • Proven experience with leading teams on the implementation and enhancements for the Global Track and trace & data stewardship eco-system
  • Communicates to other IT domains for awareness of key capability aspects, how they operate and how they are impacted.
  • Communicates broadly and maintains awareness of projects or changes to other systems that may impact enterprise systems to ensure there is no degradation of service.

 


Leadership & Management

 

 

 

  • Manages and prioritizes the flow of work in program backlog
  • Fosters a team environment and mentors members of IT team
  • Partner with DevOps Lead and global capability lead and Portfolio lead to create the business case and Deliver the Projects to support Business strategy.
  • Partner with Training &; Change Management lead to support a strategy for consistent and timely communication related to serialization applications and its adoption with its user-base
  • Partner with Implementation Vendor to ensure the effective execution of the projects and services, holding them accountable to project scope, SLAs, and KPIs.
  • Partner with the DevOps Lead and Technical Manager to capture, analyze and document functional requirements Specifications
  • Translate business requirement to functional requirements and communicate them to technical teams
  • Work as the primary point of contact for capabilities related to data stewardship
  • Participates in business customer idea elaboration and technical problem-solving with potential technical options including proposals, front-end studies, development plans, and presentations, as directed in a consulting role
  • Accountable for working with Business Process Owner, IT Compliance(for non-GxP systems) or QA (for validated systems) to identify the appropriate System Life Cycle model based on applicable regulatory requirements before presenting estimates for input to new system business case or change implementation plans
  • Leads or assists with scoping, identification of project deliverables, project time estimations, resource level estimations and ensure that the creation of project-specific documentation such as technical specifications are produced
  • Collaborate with IT Compliance (for non-GxP systems) or Validation Lead (for validated systems or qualified infrastructure) to ensure that the project plan reflects the dependencies and required deliverables of the selected System Life Cycle model
  • Partners with Quality Assurance (QA), IT Compliance and Validation resources to consult and review test plans and validation plans and ensure that issues are properly assigned, fixed, and regressed
  • Participates in the creation of Request for Proposals (RFP) from a capability perspective.
  • Partners with external business partners to meet the technical project needs as appropriate
  • Provides business knowledge expertise and mentorship to coach, train and guide new or junior IT staff, such as to suggest training course options
  • Serves as an advocate and endorses and enforces technological best practices in collaboration with solution architects
  • Facilitates and coordinates guidance to IT senior staff, working closely with solution architects, technology leads, DevOps leads and engineers
  • Ensures that business outcomes are met and proper measurements in place.
  • Keeps abreast of industry trends and advancements in relevant technology
  • Partner with Domain Architect, Technology manager, global capability leads and portfolio managers to create the business case and Deliver the Projects to support Business strategy.
  • Support Validation/QA teams on ensuring GxP compliance by leveraging corporate standard for IT change management and IT SOPs following 21 CFR Part 11 and Annex 11 requirements.
  • Excellent interpersonal, communication, and business partnering skills
  • Strategic mindset with a strong analytical foundation
  • Ability to drive continuous improvement across the team
  • Ability to operate in a cross-functional / matrix environment
  • High level of personal integrity consistent with Gilead's core values
  • Ability to analyze complex business problems and evaluate solutions
  • Ability to translate complex technical issues into business terms.
  • Excellent analytical, problem-solving, and troubleshooting skills
  • Advises clients/business analysts on discrete technology-related business problems, leveraging appropriate IT colleagues and/or vendors as appropriate. Formulates options including assessing their relative merits and risks, and works with clients/business analysts to determine the best solution.
  • Supervise a team of technical professionals, with full responsibility for performance management.

 

  • Acts as a technology mentor to team members.

 


Knowledge, Experience and Skills

Must have demonstrated implementation experience of Regulatory systems in a Bio-pharmaceutical industry.

 

 

  • Thorough understanding of Global Track and Trace domain, understanding of Global serialization regulations, working knowledge of EPCIS systems, and data stewardship/management
  • Knowledge on trends in the industry for meeting the requirements
  • Broad understanding of end to end commercial packaging, supply chain business, and data management processes
  • Good financial acumen, and experience managing financials for large and complex projects
  • Must think ahead strategically and must be able to weigh and decide between implementing new functionality by configuration vs assessment of new technology.
  • Demonstrates proficiency with one or more technology environments, with the ability to learn and apply new and emerging concepts very quickly.
  • Demonstrates in-depth knowledge of IT and the service catalog and assigned departments/business areas
  • Strong communication, excellent research skills, and learning agility to understand internal business or IT process, best practices and translate into technology needs/opportunities
  • Strong work ethic, a sense of business urgency, and the ability to work effectively with many deadlines in a complex matrix organization
  • Strong business acumen
  • Possesses strong leadership skills and ability to make critical decisions
  • Ability to find innovative ways to resolve problems
  • Strong executive-level verbal and written communications
  • Extensive experience in stakeholder management, dealing with senior management up to executive level
  • Ability to work with dispersed and global teams and locations
  • Excellent at interpersonal skills and relationship development
  • Specific experience in the Life Sciences/Pharma/Medical Devices/Healthcare industries is preferred
  • Good understanding of GxP compliance and 21 CFR Part 11 requirements.

 


Basic Qualifications

 

 

 

  • High School Degree and Fourteen Year's Experience OR Associates Degree and Twelve Years Experience OR Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' Experience OR PhD and Two Years' Experience

 


Preferred Qualifications

 

 

 

  • Typical candidates will possess 12+ years of relevant experience and BS in Computer Science or related fields or equivalent experience, or an MS and 10+ years of relevant experience.
  • Experience in pharmaceutical serialization, aggregation, and data management/stewardship areas
  • Experience working with Computer System Validation in a GxP regulated area
  • Experience with Agile, Scrum methodologies, and Cloud certification is a plus
  • Professional written, verbal, & interpersonal skills
  • Ability to multi-task effectively & work independently
  • Strong communication skills are a must
  • Experience in GxP applications (and Good Documentation Practices).
  • Experience managing a large group of consultants for delivery and sustainment and ensuring the quality of deliverables
  • Bridges gap between business and IT, for small/ simple IT systems and projects
  • Strong Listener: Be able to patiently listen to understand the business needs
  • Communication - Should be able to communicate with business stakeholders and be able to communicate complex solutions and value in business terms. Verbal communication skills are critical and the ability to adapt and learn to changing business environment and domains is a must
  • Bachelor's degree in IT, CS, Industrial engineering, Business Process Management or related discipline or an equivalent number of years of work experience
  • Experience in Life Sciences is a must.

 


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.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

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