Aseptic Compliance & Training Director

Glenmark Pharmaceuticals; Monroe (NC); On-site; USD 120,000 - 165,000; Full time

Job summary

Glenmark Pharmaceuticals Inc., USA seeks a Director of Aseptic Compliance and Training to lead training program development, certification and ongoing metrics for aseptic manufacturing at the Monroe site. The role requires SME-level guidance and ability to communicate complex aseptic concepts to a diverse trainee group.

The incumbent will oversee the certification program, track training completion, and ensure alignment with GMP standards while partnering with manufacturing and QA teams to drive

Qualifications

• Bachelor's degree in a scientific field or aseptic manufacturing.
• 8+ years of management experience in an aseptic manufacturing environment.
• Training experience is essential and demonstrated in prior roles.

Responsibilities

• Lead development of aseptic training programs and certification.
• Deliver training sessions and maintain LMS records.
• Track metrics and batch release related to aseptic operations.
• Ensure compliance with cGMP, 21 CFR, USP, ICH.
• Collaborate with cross-functional teams to improve processes.

Skills

Leadership

Training delivery

cGMP knowledge

Communication

Project management

Education

Bachelor's degree in science

Tools

Windows

Microsoft Word

Microsoft Excel

Job description

Glenmark Pharmaceuticals Inc., USA seeks a Director of Aseptic Compliance and Training to lead training program development, certification and ongoing metrics for aseptic manufacturing at the Monroe site. The role requires SME-level guidance and ability to communicate complex aseptic concepts to a diverse trainee group.

The incumbent will oversee the certification program, track training completion, and ensure alignment with GMP standards while partnering with manufacturing and QA teams to drive