Manager, IQC

INCOG BioPharma Services•Fishers, IN

6d•Onsite

About The Position

INCOG BioPharma 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.

Requirements

Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences, Engineering, or related field).
Minimum of 7 years of experience in the biopharmaceutical or pharmaceutical industry.
Minimum of 3 years of people management experience, including direct management of individual contributors in a GMP-regulated environment.
Minimum of 3 years of hands-on experience in QC physical testing of sterile injectable drug products, including autoinjectors and/or pre-filled syringes.
Experience operating or managing physical testing equipment such as Zwick universal testing machines, HVLD instruments, and/or force gauges in a GMP setting.
Experience with container closure integrity testing (CCIT) methodologies, including HVLD.
Working knowledge of applicable ISO standards for injection systems and quality management systems (e.g., ISO 11608 series, ISO 23908, ISO 13485).
Demonstrated experience with practical implementation of FDA, EMA, and other regulatory authority expectations in a QC role.
Experience with statistical sampling, AQL establishment, and defect criteria development based on ANSI/ASQ Z1.4 and PDA Technical Report guidance.
Exceptional computer skills with automated data management or analysis systems such as LIMS, JMP, or Minitab.
Experience participating in or hosting regulatory authority inspections or client GMP audits in a QC-facing role.
Must pass annual health and visual checks, including visual acuity and color blindness assessments.

Nice To Haves

Advanced degree (M.S., M.Eng., or equivalent) in a relevant scientific or engineering discipline.
Experience with assembled autoinjector functional testing per ISO 11608-5.
Familiarity with USP <1207> Container Closure Integrity Testing guidance.
Prior CDMO experience with multi-client product management responsibilities.
Experience with ERP systems (e.g., SAP) in a GMP manufacturing or CDMO environment.

Responsibilities

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 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.
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.
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 activities.
Partner with QA, Manufacturing, MSAT, Supply Chain, and Engineering to align IQC and physical testing requirements with product development, technology transfer, and commercial manufacturing activities.
Serve as the QC subject matter expert for physical testing of autoinjectors and pre-filled syringes, representing the function in client, regulatory, and internal technical forums.
Participate in new product introduction and technology transfer project teams to ensure physical testing readiness.