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 operations—including 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, right‑first‑time 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 post‑go‑live 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 long‑standing 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 right‑first‑time 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?

• On‑time, 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 bachelor's degree with at least 5 years of experience; OR a master's degree with at least 3 years of experience; OR a PhD with 0+ years of experience; OR as associate's 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 for 12 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.