Job description
The Supply Chain Business Analyst will work as an integral team member of a global serialization program, reporting to the Serialization Business Process Owner. The resource will be responsible for executing the business analysis needs for upcoming phases of Gilead's serialization program including regulatory surveillance to identify and assess new market regulatory requirements and monitoring global operations across internal sites, warehouses, CMOs and 3PLs. The BA will be part of the Level 4 Business Workstream, and will work in close collaboration with IT and all impacted business functions to assess and develop revised business processes for aggregation, from master data to serial number data maintenance.
Responsibilities:
- Assist in the roll-out of a corporate track and trace solution through sustainable and robust processes
- Lead the design and implementation of effective business processes to meet client requirements for the implementation of a global serialization and track and trace program
• Work closely with serialization team and internal business counterparts to ensure serialization solution meets regulatory timelines and deliverables - Manage and deliver quality, compliance & business oriented solutions which meet the needs of the business and address project requirements
- Monitor activities within the scope of the level 4 systems to ensure compliance with applicable regulations and internal policies and procedures
- Leverage strong business analysis, technology and data management experience to help design future state business models and processes
- Provide translation of business process requirements to use cases / user requirements
• Support completion of work-stream deliverables; work cross-functionally to ensure interdependencies and milestones are properly integrated into the project plans - Collaborate with business partners and IT to develop User Acceptance Test scenarios to test requirements as outlined in the URS / business use cases, coordinate execution and generate test summary reports
- Revise/ develop Standard Operating Procedures & policies as required per change implementations
- Participate in the drafting, reviewing & execution of various program & GMP related documents and protocols, including process maps, URS, FRS/DS, test specs, IQ, OQ, Integrated OQ & PQ, relevant summary reports and change controls
- Identify and support organizational change
Desired Skills and Experience:
- BS or MS in Engineering, Life Sciences, Supply Chain Management
- Demonstrated strong Business Analysis skills
- Previous serialization and aggregation experience. Experience with serialization and aggregation from a business perspective is strongly preferred
- Supply Chain experience in the Pharmaceutical, Biotech or Medical Device industries
- Understanding of packaging processes, warehouse and distribution operations; experience with contract packaging or 3PL distribution operations is a plus
- Understanding of typical corporate supply chain IT systems, such as ERP, MRP, WMS, MDM systems
- Strong written and oral communication skills
- Strong ability to be proactive and to manage and prioritize own actions
- Ability to work in a team-oriented, collaborative environment
- Ability to be flexible and change activities quickly, based on business need
- Ability to facilitate meetings and follow up with resulting action items
- Previous experience working as part of a large, multi-disciplinary team completing full project life-cycle implementations
- Working knowledge of software development life cycle and operational support methodologies
- Proficient knowledge of MS Excel, Word, Visio, PowerPoint
