GMP Training & Compliance Lead for Biologics Ops

MSD; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement benefits

Paid holidays, vacation, and sick days

Job summary

MSD's Biologics Process Research & Development organization within our Company Research Labs supports the Next Generation Biologics facility in Rahway, NJ. The Sr.

Specialist coordinates GMP training, qualification, LMS activities, and documentation to ensure compliant operations across GMP programs. In partnership with Operations, Quality, and SMEs, this role maintains training curricula, tracks qualification, generates reports, and drives continuous improvement using digital learning tools and

Qualifications

• Bachelor's or Master’s degree with relevant GMP/training experience.
• Experience coordinating GMP training and qualification programs.
• Experience managing training records and documentation in GMP environments.
• Ability to monitor compliance, produce dashboards, and drive improvements.

Responsibilities

• Coordinate GMP training and qualification programs supporting NGB Operations.
• Establish role-based training and qualification requirements with Operations leadership, SMEs, and process owners.
• Monitor training compliance and qualification status, identify gaps, and drive remediation activities.
• Manage training records and controlled documents in line with cGMP, Data Integrity, and Records Management requirements.
• Administer LMS activities: curriculum management, training assignments, qualification tracking, and reporting.
• Lead in-person and virtual training sessions and coordinate onboarding, qualification, and cross-training programs.
• Prepare qualification status reports, dashboards, and training documentation.

Skills

GMP training coordination

Curriculum management

LMS administration

Data integrity

Documentation practices

Qualification tracking

Training delivery

Cross-functional collaboration

Analytical skills

Change management

Education

Bachelor's degree in Biological Sciences or Engineering

Master's degree with relevant experience

Tools

LMS

Job description

MSD's Biologics Process Research & Development organization within our Company Research Labs supports the Next Generation Biologics facility in Rahway, NJ. The Sr.

Specialist coordinates GMP training, qualification, LMS activities, and documentation to ensure compliant operations across GMP programs. In partnership with Operations, Quality, and SMEs, this role maintains training curricula, tracks qualification, generates reports, and drives continuous improvement using digital learning tools and