Senior GMP Training & Compliance Lead

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

Job summary

Merck & Co in Rahway, NJ, is seeking a Sr. Specialist, Training Coordination, Compliance Operations, to coordinate GMP training and qualification programs for the Next Generation Biologics facility.

You will manage LMS, qualification tracking, and documentation, ensuring training compliance across cGMP standards. The role partners with Operations, Quality, and SMEs to establish role-based training, monitor gaps, drive remediation, and implement digital learning tools.

Qualifications

• Bachelor's degree in Biological Sciences, Engineering, or related discipline with 5+ years of experience; Master’s with 3+ years preferred.
• Experience in GMP training and qualification programs in pharma/biotech or regulated environments.
• Proficiency in LMS administration, training metrics, and compliance reporting.

Responsibilities

• Coordinate GMP training and qualification programs supporting NGB Operations.
• Monitor training compliance and qualification status; drive remediation activities.
• Administer and maintain LMS activities including curriculum management and reporting.
• Lead instructor-led, virtual, and on-the-job training programs.
• Prepare qualification status reports and compliance dashboards.
• Support digital learning tools and training documentation.

Skills

LMS administration

GMP training

Qualification management

Curriculum administration

Data analytics

Regulatory inspections support

Cross-functional collaboration

Education

Bachelor's degree in Biological Sciences/Engineering

Master's degree (preferred)

Tools

LMS

Job description

Merck & Co in Rahway, NJ, is seeking a Sr. Specialist, Training Coordination, Compliance Operations, to coordinate GMP training and qualification programs for the Next Generation Biologics facility.

You will manage LMS, qualification tracking, and documentation, ensuring training compliance across cGMP standards. The role partners with Operations, Quality, and SMEs to establish role-based training, monitor gaps, drive remediation, and implement digital learning tools.