Manager of Inspection (MB)

INCOG BioPharma Services • Fishers, IN

2d • $130,000 - $140,000 • Onsite

About The Position

INCOG BioPharma is seeking a seasoned leader with extensive subject matter expertise in the inspection and packaging of sterile drug products. The primary purpose of this role is to provide strategic leadership, operational management, and technical excellence across our 24/5 inspection operations, overseeing three shifts of Inspection Supervisors and their teams. The Manager of Inspection will be responsible for the overall vision, strategy, and execution of the visual inspection program within INCOG BioPharma Operations. This role will drive continuous improvement, ensure regulatory compliance, develop talent across all shifts, and serve as the primary liaison between inspection operations and senior leadership.

Requirements

• Extensive subject matter expertise in the inspection and packaging of sterile drug products.
• Functional knowledge of industry guidance and requirements applicable to visual inspection, including USP <790> and <1790>; FDA Draft Guidance: Inspection of Injectable Products for Visible Particulates (2021); PDA Technical Reports, and European Pharmacopoeia 2.9.20: Particulate Contamination: Visible Particles
• Awareness of industry trends, including FDA actions, in manual and automated inspection processes
• SME on Knapp-Abramson Analysis Framework, individual certification for manual visual inspection, defect kit creation, qualification, and control; and qualification strategies for SASI and AIM
• 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.

Nice To Haves

• Seasoned leader with extensive subject matter expertise in the inspection and packaging of sterile drug products.

Responsibilities

• Develop and execute the strategic vision for the inspection department, including short-term and long-term goals aligned with company objectives.
• Oversee the implementation, optimization, and continuous improvement of the visual inspection program across all shifts.
• Lead cross-functional initiatives to advance inspection technologies, automation, and packaging capabilities.
• Establish and monitor key performance indicators (KPIs) and quality metrics for inspection operations.
• Provide direct leadership and management to three Inspection Supervisors (1-2 per shift) and indirect oversight of their inspection teams.
• Ensure seamless 24/5 inspection operations through effective shift coordination, scheduling, and resource allocation.
• Monitor production schedules, capacity planning, and workflow optimization across all shifts.
• Coordinate with the supervisors to host shift handoffs to ensure continuity of operations and communication flow.
• Resolve escalated operational issues and ensure rapid response to production challenges.
• Ensure compliance with cGMP requirements (current good manufacturing practices) across all inspection operations.
• Serve as the subject matter expert for regulatory inspections related to visual inspection and packaging.
• Develop, review, and approve visual inspection specifications, SOPs, and batch records.
• Lead deviation investigations, CAPA initiatives, and risk assessments related to inspection operations.
• Interface with Quality Assurance, Quality Control, and Regulatory on compliance matters.
• Maintain expert knowledge of FDA, EMA, and other global regulatory requirements for sterile product inspection.
• Recruit, develop, and retain high-performing Inspection Supervisors and team members.
• Conduct performance management, coaching, and career development for direct reports.
• Establish training programs and competency assessments for visual inspection personnel across all shifts.
• Foster a culture of accountability, continuous learning, and operational excellence.
• Promote cross-shift collaboration and knowledge sharing.
• Champion employee engagement, safety, and INCOG’s core values.
• Provide technical guidance on automated visual inspection systems, semi-automated equipment, and manual inspection processes.
• Evaluate and implement new inspection technologies and packaging innovations.
• Lead qualification and validation activities for inspection equipment and processes (IQ/OQ/PQ).
• Collaborate with Engineering, Technical Services, and external vendors on equipment optimization.
• Stay current with industry best practices, emerging technologies, and regulatory trends.
• Partner with Manufacturing, Quality, Supply Chain, and Technical Services to ensure seamless operations.
• Represent inspection operations in management meetings, production planning sessions, and strategic initiatives.
• Support client audits, regulatory inspections, and customer presentations.
• Collaborate with Business Development on new product assessments and feasibility studies.

Benefits

• We are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed