Solution Implementation Lead - GxP

Role Summary

Solution Implementation Lead - GxP at Swiftwater, PA. Responsible for the Swiftwater site implementation of global Smart Factory solutions that support Manufacturing & Supply operations, aligning with global strategies and core models. Drives digital innovation and modernization at the site level.

Responsibilities

• Represent the site in the implementation of global Smart Factory solutions and facilitate interaction with Quality, Digital, and Business functions (site and global).
• Ensure the system remains fit-for-purpose and aligned with evolving core models and business needs.
• Ensure system usage meets business needs and supports operational efficiency.
• Provide training and support to end users, promoting standardization and best practices.
• Lead the network of key users and provide Level 2 and Level 3 support.
• Collaborate with the Smart Factory Head, global BSO, site Business System Owners, site Quality Validation, and other stakeholders to align local needs with global strategy.
• Manage deviations, CAPAs, change control, documentation, training, audit trail reviews, and access management related to the implementation of the new solution.
• Develop the local business continuity strategy and documentation to transfer the solution to local run mode after project closure.
• Investigate and resolve incidents related to the system during hyper care.
• Plan system-related activities and provide visibility on priorities.
• Support users in adopting digital solutions and develop a change plan for the business transformation.

Qualifications

• Required: 2+ years of Pharmaceutical Industry experience and 2+ years of computerized system implementation or project management experience.
• Required: Strong GxP and Data Integrity knowledge.
• Education: Bachelor‚Äôs Degree in Engineering, Life or Data Sciences or related discipline preferred; combination of education and experience considered.
• Preferred: Experience leading project teams or continuous improvement initiatives; familiarity with SAP, Siemens, Veeva, Power BI.

Skills

• GxP and Data Integrity
• Change management
• System governance and compliance
• Training and user support
• Project management and cross-functional collaboration
• Digital solution adoption and transformation

Education

• Bachelor‚Äôs Degree - Engineering, Life or Data Sciences or related discipline (preferred)

Additional Requirements

• This is a hybrid role requiring 4 days a week onsite.