GxP Training Lead: Compliance & Coaching

INCOG BioPharma Services; Fishers (IN); On-site; USD 80,000 - 115,000; Full time

Job summary

INCOG BioPharma Services seeks a GxP Training Supervisor to lead Manufacturing Training Specialists and ensure compliant GxP training delivery. You will coordinate classroom, OJT, and administrative training activities, quality review eQMS records, and support audits.

The role requires strong leadership, regulatory knowledge, and collaboration with Quality, Manufacturing, and IT teams. The ideal candidate has a track record in GMP environments, experience with eQMS systems such as Veeva Vault,

Qualifications

• Minimum 1-2 years of supervisory or lead-level experience.
• 3-5 years of training delivery, facilitation, OJT, and program administration.
• Demonstrated knowledge of GxP manufacturing and regulatory requirements (FDA 21 CFR Parts 11 and 211; ICH GxP).
• Pharmaceutical/manufacturing background in regulated environments.
• 1-2 years of experience with eQMS/eLMS (preferably Veeva Vault).
• Certification or equivalent in Education, Training, Communications or related field.
• Excellent verbal and written communication; ability to explain complex regulatory concepts clearly.
• Proven ability to lead, coach, and develop team members; strong cross-functional collaboration.

Responsibilities

• Directly supervise Manufacturing GxP Training Specialists and manage training delivery priorities.
• Coach, mentor, and perform performance management for direct reports.
• Oversee classroom and OJT delivery, ensuring compliant instruction of GxP principles.
• Review competency assessments for consistent learning evaluation across trainers.
• Maintain training records and curricula to be audit-ready under FDA/ICH guidance.
• Serve as escalation point for eQMS issues and system changes.
• Collaborate with departments to deploy effective OJT programs and training improvements.

Skills

Leadership

Training delivery

GxP knowledge

eQMS administration

Education/certification

Communication

People management

Assessment & evaluation

Organizational skills

Adaptability

Education

Education/Certification

Job description

INCOG BioPharma Services seeks a GxP Training Supervisor to lead Manufacturing Training Specialists and ensure compliant GxP training delivery. You will coordinate classroom, OJT, and administrative training activities, quality review eQMS records, and support audits.

The role requires strong leadership, regulatory knowledge, and collaboration with Quality, Manufacturing, and IT teams. The ideal candidate has a track record in GMP environments, experience with eQMS systems such as Veeva Vault,