GMP/GxP Training Compliance Manager

Responsibilities

• Lead the training program strategy, structure, and implementation.
• Assist GMP and GXP work areas in developing, implementing, and maintaining On-the-Job Training (OJT) programs, including new hire GMP and GXP training for all employees.
• Investigate quality issues, determine root cause, and execute training-related CAPAs.
• Design, develop, facilitate, and deliver general site and technical training content (including cGXP training), including instructional tools, hands-on exercises, and exams.

Qualifications

• Bachelor’s degree
• 10 years relevant experience in pharma/biotech manufacturing, or similar regulated environment
• 5 years of experience leading training programs and delivering training
• Experience in developing and designing courses, training plans, and ensuring competency requirements
• Experience in pharmaceutical and GMP cGXP regulated environment
• Working knowledge of pharmaceutical industry regulations and expectations

Work Environment

The role requires working Monday to Thursday onsite from 8:00 AM to 5:00 PM, with occasional extended hours till 5:30 PM - 6:00 PM to assist with onsite training for the second shift.