Training and Documentation Manager– Pharma (Onsite – New Brunswick, NJ)

Training and Documentation Manager– Pharma (Onsite – New Brunswick, NJ)

We are seeking a Training and Documentation Manager– Pharma for a global pharmaceutical client. The focus of the role is to ensure day-to-day compliance with GxP documentation and training. The candidate will work with multiple departments across Product Development to effectively communicate and manage all training and GxP documentation-related issues. The position is responsible for managing controlled documentation (Standard Operating Procedures, Forms, other controlled documents, Training docs, etc.) for the team.

This is a 40-hour per week, 6-month contract (extensions possible), 100% onsite role in New Brunswick, NJ

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

Responsibilities

• Training and Documentation:
• Handle daily training and documentation tasks, ensuring compliance with GxP documentation and data integrity principles
• As trainee SME, develop and evaluate training curricula, monitor training materials, and assess program effectiveness.
• Conduct training impact assessments and create Role Based Training matrices.
• Generate training metrics, create job aids/end- to-end workflows and conduct team trainings as required.
• Content Management:
• Manage PD Electronic Document Management Systems (e.g., BMSDocs/Veeva) by creating, reviewing, and maintaining CSO-controlled documents.
• Oversee documents scheduled for periodic reviews and updates related to CAPAs.
• Digital Solutions and SharePoint Management:
• Establish and manage a SharePoint site to enhance team communication and collaboration.
• Identify, implement and support digital solutions to replace paper-based processes or enhance existing processes.
• Evaluate and recommend electronic solutions to streamline workflows
• Quality and Compliance:
• Perform quality investigations, including root cause analysis, CAPAs and ensure timely completion of investigations.
• Ensure compliance with GxP documentation and data integrity principles in daily work.
• Continuous Improvement:
• Identify opportunities for process optimization and implement best practices.
• Collaborate with cross-functional teams to drive continuous improvement initiatives.
• Monitor and analyze performance metrics to identify areas for improvement.
• Facilitate training sessions and workshops to promote a culture of continuous improvements.
• Team Collaboration and Problem Solving:
• Address day-to-day challenges independently in a timely and professional manner.
• Collaborate effectively with team members to resolve routine issues.
• Exercise good judgment in identifying when to escalate technical or business challenges to upper management
  
  

Requirements

• 4 years of experience with Training Management systems/principles (e.g., SuccessFactors, ComplianceWire) and QMS Documentation Systems (e.g., EDMS, Veeva).
• Strong background in Good Manufacturing Practices (GMP) and GxP documentation, with familiarity with Data Integrity principles.
• Proficiency in Excel, Word, Visio, SharePoint, PowerPoint, etc
• Experience in deviation writing, change controls, CAPA metrics/generation and management
• Highly experienced in creating, managing, and maintaining SharePoint sites; experience with AI tools is a plus.
• Bachelor's degree required in field of science
  
  

Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the Training and Documentation Manager– Pharma (Onsite – New Brunswick, NJ) role.

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation: $53/hr. - $57.50/hr.