Manager, IQC

Description

Job Description

INCOG Bio Pharma Services is seeking a Manager, Incoming Quality Control and Physical Testing to join our Quality Control team in Fishers, Indiana. This role provides strategic leadership and functional oversight for three integrated QC programs:
Incoming Quality Control (IQC), in-process physical testing, and finished goods physical testing for sterile injectable drug products, including autoinjectors and pre-filled syringes.

The Manager, Incoming Quality Control and Physical Testing reports to the Senior Director of Quality Control and is accountable for the performance, development, and compliance of the IQC and Physical Testing groups, including direct management of QC individual contributors. This position is critical in ensuring all incoming materials, in-process samples, and finished drug products meet established specifications and quality standards while championing INCOG's Quality Mindset with a strong focus on attention to detail, efficiency, on-time delivery, and continuous improvement.

The successful candidate will partner cross-functionally with Quality Assurance, Supply Chain, Manufacturing Science & Technology (MSAT), Manufacturing, and Engineering while providing hands-on leadership and technical expertise in physical testing operations.

Essential Job Functions:

People & Team Leadership

• Directly manage QC individual contributors responsible for IQC and physical testing operations, providing clear direction, performance feedback, and developmental support.
• Foster a culture of quality, accountability, and operational excellence across all IQC functional areas.
• Set team and individual performance goals aligned to departmental KPIs and INCOG quality objectives; conduct formal performance reviews and ongoing coaching conversations.
• Support hiring, onboarding, and training of IQC personnel; ensure training records are current and compliant with applicable SOPs and regulatory requirements.
• Articulate complex technical and quality issues effectively to a range of audiences including site leadership, clients, and regulatory representatives.

Incoming Quality Control (IQC) Program Management

• Oversee the execution and continuous improvement of the material qualification program, including development and maintenance of material specifications and sampling plans.
• Direct the coordination of physical sampling, testing, third-party analytical sampling, and ERP transaction execution for incoming raw materials and components.
• Manage the authoring and issuance of inspection records for incoming materials, components, and container closure systems.
• Represent IQC in material planning and Ready to Execute meetings, providing updates on material sampling, qualification status, and release readiness.
• Oversee investigations arising from IQC non-conformances and ensure timely disposition of held materials in alignment with QA requirements.

In-Process & Finished Goods Physical Testing

• Provide management oversight for in-process and finished goods physical testing of autoinjectors and pre-filled syringes, ensuring all testing is performed in compliance with applicable SOPs, client specifications, and regulatory requirements (FDA, EMA, ICH, ISO).
• Manage physical testing programs including container closure integrity testing (CCIT) using High Voltage Leak Detection (HVLD) instrumentation; glide force, break-loose force, and extrusion force testing using the Zwick universal testing machine; needle cap and needle shield removal force testing; cap removal force testing; activation force, trigger force, and injection force testing for autoinjectors; and additional functional force testing using calibrated force gauges.
• Ensure all physical testing instrumentation (Zwick, HVLD, force gauge) is maintained, calibrated, and qualified in accordance with site equipment qualification and calibration programs.
• Oversee the review and interpretation of physical test results; support trending, statistical analysis, and timely escalation of anomalous results.
• Partner with MSAT and Manufacturing to define in-process and finished goods acceptance criteria aligned with product specifications and applicable ISO standards.

Investigations, CAPA & Quality Systems

• Lead or provide management oversight for laboratory investigations associated with OOS, OOT, and non-conformance events, applying systematic troubleshooting methodologies (e.g., fishbone analysis, 5-Why).
• Ensure investigations are technically sound, completed within established timelines, and closed with appropriate root cause identification and CAPA implementation.
• Utilize and maintain QMS, LIMS, and related automated systems; review and approve QC documentation including sampling plans, test methods, specifications, and investigation reports.
• Apply statistical tools (e.g., JMP, Minitab) for trend analysis and data-driven continuous improvement.
• Support preparation, coordination, and hosting of FDA, EMA, and client GMP audits and inspections related to IQC and physical testing…