Solution Implementation Lead - GxP

Job Title: Solution Implementation Lead

Location: Swiftwater, PA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The Local Solution Implementation Lead is responsible for Swiftwater site implementation of global Smart Factory solutions that support Manufacturing & Supply operations. This role reports to the Swiftwater Smart Factory Head and is crucial in driving digital innovation and modernization at the site level while maintaining alignment with global strategies, processes, and core models. 

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

 **This a hybrid role - 4 days a week onsite - required. **

Main Responsibilities:

Governance & Compliance 

• Represent the site in the implementation of global Smart Factory solutions and facilitate the interaction with Quality, Digital, and Business functions (site and global). 

System Oversight 

• Ensure the system remains fit-for-purpose and aligned with evolving core models and business needs. 

System Use & Support 

• 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. 

Collaboration Focus 

• Collaborate closely with the Smart Factory Head, global BSO, site Business System Owns, site Quality Validation and other stakeholders to ensure local needs are represented and aligned with global strategy. 

Quality Management 

• 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 

Resource Management 

• Plan system-related activities and provide visibility on priorities. 

Change Management 

• Support users in adopting digital solutions and develop a change plan for the business transformation supporting the change 

About You

Required Qualifications 

• Work Experience: 2+ years of Pharmaceutical Industry Experience and 2+ years of Computerized System implementation or Project Management experience 

• Minimum required skills: Strong GxP and Data Integrity knowledge.  

• Education: Bachelor’s Degree - Engineering, Life or Data Sciences or related discipline - preferred.  A combination of education and experience will be considered.

Preferred Qualifications: 

• Work Experience: Experience with successfully Leading Project teams or Continuous Improvement Initiatives 

• Technical skill: Experience with standard industry systems including but not limited to: SAP, SIEMENS, Veeva, & PowerBI