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