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Manager of Inspection Summary

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.

Essential Job Functions:

Strategic Leadership & Program Management

• 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.

Operational Management & Multi-Shift Oversight

• 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.

Quality & Regulatory Compliance

• 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.

People Development & Team Leadership

• 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.

Technical Expertise & Innovation

• 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.

Cross-Functional Collaboration

• 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.

Special Job Requirements:

• 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

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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