Standard Operating Procedures (SOPs)
Forms
Protocols
Reports
Global Document Elements (GDEs)
Work Instructions
Training Documents
Other controlled GMP documentation
Ensure documents comply with Good Documentation Practices (GDP), cGMP requirements, site procedures, and global standards.
Perform periodic reviews of controlled documents and drive completion of required updates.
Review existing procedures for accuracy, consistency, and process alignment.
Identify opportunities to improve document effectiveness, usability, and compliance.
Cross-Functional Coordination
Facilitate document review meetings and revision workshops with subject matter experts and stakeholders, across various sites in the network
Coordinate comment resolution across multiple functional groups.
Consolidate feedback and incorporate approved revisions into final documents.
Drive stakeholder alignment in partnership with the sponsoring area owner on document content, process changes, and implementation plans.
Partner with Quality, Validation, Engineering, Manufacturing, and Technical Services to ensure documentation supports operational needs.
Project & Revision Management
Manage multiple complex document revisions simultaneously.
Develop and maintain document revision schedules and status trackers.
Monitor progress against established timelines and commitments.
Escalate risks, delays, and resource constraints as appropriate.
Lead efforts to complete high-priority and inspection-related documentation updates.
Metrics & Operational Support
Generate and analyze documentation performance metrics and reports.
Track key performance indicators related to document health, overdue reviews, revision cycle times, and compliance commitments.
Prepare performance metrics for communication to leadership and stakeholders
Drive actions to improve documentation effectiveness, compliance, and right-first-time performance.
Support audit and inspection readiness activities through documentation monitoring and reporting, if required.
Continuous Improvement
Identify opportunities to streamline documentation processes and workflows.
Participate in process improvement initiatives and digital transformation efforts.
Recommend and implement solutions that improve document quality, compliance, and efficiency.
Contribute to standardization efforts across manufacturing organizations and sites.
Basic Qualifications
Preferred Qualifications
Experience in a GMP-regulated manufacturing environment.
Experience authoring and revising SOPs, protocols, reports, forms, and controlled documentation.
Strong technical writing and document management skills.
Experience facilitating cross-functional meetings and stakeholder reviews.
Knowledge of Good Documentation Practices (GDP) and cGMP requirements.
Experience using electronic document management systems (e.g., Veeva, CDOCS, EDMS, TrackWise, etc.).
Ability to manage multiple priorities and deadlines simultaneously.
Strong project management and organizational skills.
Experience generating and analyzing operational metrics and performance reports.
Demonstrated ability to influence stakeholders without direct authority.
Strong communication, collaboration, and facilitation skills.
Experience leading continuous improvement initiatives.
Competencies
Consistent with the Manufacturing Senior Associate competency model, success in this role requires demonstrated capability in:
Demonstrating Technical Expertise
Operating with Precision
Working in Partnership
Troubleshooting and Solving Problems
Inspiring High Performance
Striving for Your Best
Key Measures of Success
On-time completion of document revisions
Reduction in overdue document reviews
Right-first-time document approval rate
Cycle time for document revision and approval
Compliance with GMP and documentation standards
Inspection readiness and audit support effectiveness
Stakeholder satisfaction
Continuous improvement implementation and value delivery
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