Incoming Quality Control Manager

The Manager for Incoming Quality Control (IQC) and Physical Testing provides strategic leadership and functional oversight for three integrated QC programs: IQC, in-process physical testing, and finished goods physical testing for sterile injectable drug products, including autoinjectors and pre-filled syringes. This role reports to the Snr Director of QC, and is accountable for the performance, development, and compliance of the IQC and Physical Testing groups, including direct management of ~8 team members.

The Manager partners cross-functionally with Quality Assurance, Supply Chain, Manufacturing Science & Technology (MSAT), Manufacturing, and Engineering to ensure that all incoming materials, in-process samples, and finished drug product meet established specifications and quality standards. The role leads strategy and direction across all programs within scope, champions a Quality Mindset with a focus on attention to detail, efficiency, and on-time delivery, and drives continuous improvement through data-driven decision making and systematic problem-solving.

There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.

At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.

• 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.

• Oversee the execution and continuous improvement of the material introduction 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 raw materials and components.
• 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.

• 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 but not limited to: container closure integrity testing (CCIT); glide force, break-loose force, and extrusion force testing; needle cap and needle shield removal…