INCOG BioPharma Services Careers

Description

Summary

INCOG is seeking a highly capable GxP Training Supervisor to lead and coordinate the day-to-day activities of the site's Manufacturing Training Specialists. This role is accountable for ensuring that training delivery, competency assessment, curriculum administration, and training records management are executed consistently, on schedule, and in full compliance with FDA and ICH GxP expectations.

The Supervisor will provide direct oversight, coaching, and performance management for Manufacturing Training Specialists, coordinate workload and scheduling across classroom, on-the-job (OJT), and administrative training activities, and serve as the primary point of escalation for training compliance issues, curriculum gaps, and cross-departmental training needs. This role partners closely with the GxP Training Manager to translate department strategy and priorities into daily execution, while acting as a secondary administrator and quality reviewer for the Veeva Vault electronic Quality Management System (eQMS) training module. The ideal candidate combines strong people-leadership skills with hands-on GxP training expertise to ensure INCOG personnel are qualified, compliant, and inspection-ready at all times.

Essential Job Functions

Team Leadership & Supervision

• Directly supervise Manufacturing GxP Training Specialists, including day-to-day work assignment, scheduling, and prioritization of training delivery and administrative activities.

• Conduct performance management activities including goal-setting, coaching, performance reviews, and development planning for direct reports.

• Mentor and develop team members' instructional, assessment, and eQMS administration skills; identify training and cross-training needs within the team.

• Support recruitment, onboarding, and qualification of new GxP Training team members.

• Foster a collaborative, accountable team culture aligned with INCOG's values of All In, Lean Forward, and Pull for the Team.

Training Delivery Oversight

• Oversee and quality-check classroom training and on-the-job training (OJT) delivered by INCOG training facilitators , ensuring engaging, accurate, and compliant instruction of GxP principles, quality systems, and role-specific competencies.

• Review competency assessment methods and results to confirm consistent application of learning evaluation standards across trainers and departments.

• Identify trends in assessment outcomes indicating need for remedial training, curriculum revision, or facilitator coaching.

• Ensure training delivery schedules support new-hire onboarding timelines and ongoing/annual training compliance deadlines.

Training Administration & eQMS Oversight

• Provide oversight and quality review of training program administration within the Veeva Vault eQMS, supporting and guiding training personnel in record entry, curriculum assignment, and system configuration.

• Ensure training records, testing documentation, and curricula are complete, accurate, traceable, and audit-ready in accordance with FDA, ICH GxP, and INCOG requirements.

• Support annual curriculum review cycles and sitewide curriculum system management, including approval routing and change control.

• Serve as an escalation point for eQMS training system issues, working with IT/system administrators as needed.

Compliance & Audit Readiness

• Ensure team activities comply with all applicable regulatory, quality, and Environmental Health & Safety (EHS) requirements.

• Maintain current knowledge of FDA 21 CFR Parts 11 and 211, ICH GxP guidance, and industry training-related inspection findings; communicate relevant updates to the team.

• Coordinate preparation and provision of training records and documentation in support of client and health authority audits, including direct participation in audits and inspections as a training subject matter expert.

• Support and contribute to CAPA, deviation, and continuous improvement activities related to training compliance and effectiveness.

Reporting, Metrics & Continuous Improvement

• Compile and deliver routine reporting on training system status, compliance health, and key training metrics to the GxP Training Manager and stakeholders.

• Analyze training compliance and effectiveness data to identify systemic gaps and recommend risk-based corrective actions.

• Identify and drive opportunities for training delivery, curriculum, and process improvements in partnership with training leadership and subject matter experts.

• Participate in and support broader training team continuous improvement initiatives.

Cross-Functional Collaboration

• Develop and maintain collaborative working relationships with department leaders, Quality, Manufacturing, Technical Services, and other internal clients to understand and address training needs.

• Partner with departments on the deployment and effectiveness of OJT programs specific to their operations.

• Communicate training progress, compliance status, and risk areas clearly to relevant stakeholders and leadership.

Other Duties

• Work flexible hours/schedules as needed to support training delivery and team coverage across INCOG operations.

• Support additional Quality and operational initiatives as assigned to advance organizational excellence.

Special Job Requirements

• Supervisory/Leadership Experience: Minimum 1-2 years of experience leading, supervising, or providing lead-level direction to a team, preferably in a training, quality, or GMP manufacturing function.

• Training Experience: Minimum 3-5 years of combined experience in training delivery/facilitation, OJT, and/or training program administration.

• GxP & Regulatory Knowledge: Demonstrated practical knowledge of GxP manufacturing and regulatory requirements for pharmaceuticals, including FDA 21 CFR Parts 11 and 211 and ICH GxP guidelines.

• Pharmaceutical/Manufacturing Background: Demonstrated knowledge of pharmaceutical manufacturing processes and/or related GxP operations; working knowledge of regulated manufacturing environments.

• eQMS/eLMS Administration: Minimum 1-2 years of experience utilizing an electronic Quality or Learning Management System (eQMS/eLMS), preferably Veeva Vault.

• Education/Certification: Certification (or equivalent experience) in Education, Training, Technical Writing, Communications, or a similar field.

• Communication & Facilitation Skills: Excellent verbal and written communication skills; demonstrated ability to explain complex technical and regulatory concepts clearly to diverse audiences.

• People Management & Coaching: Proven ability to lead, coach, mentor, and develop team members; strong interpersonal skills and ability to build trusting relationships across the organization.

• Assessment & Evaluation: Ability to oversee development, implementation, and analysis of uniform learning assessments and training effectiveness metrics.

• Organizational & Detail Orientation: Strong organizational skills with the ability to manage competing priorities, schedules, deadlines, and documentation accuracy in a fast-paced environment.

• Adaptability & Customer Service: Ability to adapt to diverse learners, departments, and delivery situations; strong customer service mindset and cross-functional collaboration skills.

Additional Preferences

• Degree and/or certification(s) focusing on adult learning principles.

• Prior experience in training delivery, training administration, and/or team leadership within an aseptic manufacturing facility.

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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