Smart Document System (SDS) Deployment Lead (Secondment 12 24 Months)

WHY PATIENTS NEED YOU

The SDS Deployment Lead is responsible for planning executing and sustaining the rollout of the Smart Document System (SDS) across all Kalamazoo site operationsincluding Quality API Operations and Drug Product Operations.

This role ensures that SDS replaces legacy paper-based and electronic logbook/form workflows (including PLOG and PDOCS-based forms) with standardized validated compliant digital processes aligned with Global Quality PGS and Revolution initiatives.

The SDS Deployment Lead partners closely with Quality Business Systems (system ownership) Digital functional SMEs and site leadership to deliver a structured phased deployment that strengthens data integrity improves efficiency and drives adoption across a large and complex manufacturing environment.

HOW YOU WILL ACHIEVE IT

Deployment Leadership & Strategy

• Lead development and execution of the site-wide SDS deployment roadmap covering Quality API DP laboratories and supporting operations.

• Define deployment waves resource requirements schedules and integration points with Revolution deliverables and global SDS rollouts.

• Partner with local system owner(s) (e.g. Quality Business Systems) to ensure alignment with corporate SDS standards validation packages and configuration governance.

Stakeholder Engagement & Communication

• Engage site leadership functional managers and end users to communicate deployment plans expectations and timelines.

• Serve as the primary point of contact for SDS deployment across Kalamazoo ensuring transparency readiness and alignment.

• Coordinate with global SDS teams (Process Core Team Deployment Team Digital Product Owner) on enhancements issues and change requests.

Requirements Design & Form Development

• Facilitate collection of user requirements for global local and revolutionized forms/logbooks.

• Oversee design configuration and testing of SDS FORMs workflows formulas and logic rules in partnership with SMEs and form authors.

• Ensure alignment with harmonized GSOPs GWIs and global standards for form structure logic and documentation.

• Review forms for usability rightfirsttime execution data integrity audit trail clarity and compliance.

Validation Compliance & Documentation

• Coordinate site activities required to adopt corporate SDS validation and complete site-specific validation deliverables.

• Ensure forms logbooks workflows and configurations meet all GMP Part 11 data integrity and audit requirements.

• Partner with Quality Digital Operations and Compliance to manage and drive site change controls aligned with requirements from Digital SOP-00098 PGS Digital Global Regulatory Compliance Procedure GSOP-000105 Computerized System Assurance and GSOP-000106 Electronic Records and Electronic Signatures (ERES) Data Integrity system audits and risk assessments at site are implemented per requirements in GWI-000375 Data Review Strategy and Execution impact assessments and system documentation updates.

Training Adoption & Support

• Develop and execute a structured training plan for authors reviewers approvers and end-users (Quality API DP).

• Ensure teams follow prerequisites (e.g. SDS curriculum completion) and maintain readiness for system access.

• Promote strong adoption practices including user support channels site SMEs and postgolive hypercare.

• Collaborate with site training function training leads and Digital to maintain ongoing capability.

Continuous Improvement & Sustainment

• Monitor system performance usage trends form execution issues and backlog items.

• Identify opportunities for process optimization expanded functionality or accelerated digitization across legacy forms/logbooks.

• Partner with global teams to influence enhancements to SDS logic reporting navigation and usability.

• Ensure processes are updated to reflect SDS execution (SOPs work instructions system descriptions).

Key Competencies what will make you successful

• Change Leadership Ability to drive adoption across diverse functions and shift longstanding paper-based processes to digital execution.

• Technical Acumen Strong understanding of form logic data flows system behavior and integration points.

• Quality & Compliance Mindset Ensures robustness traceability and rightfirsttime execution.

• Collaboration & Influence Effectively partners with SMEs supervisors engineers QA and Digital teams across the site.

• Project Execution Excellence Structured organized and capable of coordinating deployment waves in a complex environment.

Success Matters what will success look like

• Ontime validated deployment of SDS across targeted functions.

• Adoption rate training completion and reduction of paper-based forms/logbooks.

• Improved data integrity audit readiness and execution reliability.

• Positive user feedback and sustained usage metrics.

• Alignment to Revolution priorities and global SDS implementation strategy.

QUALIFICATIONS

Must-Have

• Applicant must have a bachelors degree with at least 5 years of experience; OR a masters degree with at least 3 years of experience; OR a PhD with 0 years of experience; OR as associates degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.

• Working knowledge of GMP data integrity and regulated system validation.

• Experience with manufacturing or quality systems in Quality API or Drug Product operations.

• Strong project management and stakeholder engagement skills.

• Ability to lead cross-functional teams and manage work across multiple operational areas.

Nice-to-Have

• Experience with PLOG PDOCS forms or digital logbook/form systems.

• Understanding of Revolution processes harmonized GSOPs and global standards.

• Familiarity with SDS design elements such as formulas logic conditions signatures audit trail behavior and workflow configuration.

• Experience working with global teams (Digital Process Owners Deployment Teams).

• Lean/OpEx experience supporting digitization or paperless workflow transformations.

• Prior involvement in system deployments form/logbook creation LIMS/PLM/QMS/digital system rollouts or process automation.

OTHER JOB DETAILS

• Last Date to Apply for Job:February 24 2025

• Additional Location Information:N/A

• Eligible for Relocation Package NO

• Secondment 12-24 months

• If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for12 months or longer you will be required to turn in your fleet vehicle for the duration of the non-driving secondment. Please refer to the Fleet Policy and Procedures document for more information.

• Occasional Lifting sitting standing walking bending ability to perform mathematical calculations and ability to perform complex data analysis.

• There will be no change to your current work location.

• Position is on Premise.

Relocation assistance may be available based on business needs and/or eligibility.