Incoming Quality Control Manager

Lead Candidate; Fishers (IN); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Paid vacation

Paid sick time

401(k)

Job summary

INCOG seeks a Manager for Incoming Quality Control (IQC) and Physical Testing to lead IQC, in-process testing, and finished goods testing for sterile injectable products. You will manage a team of ~8 and partner cross-functionally with QA, Manufacturing, MSAT, and Engineering to ensure materials and products meet specifications and regulatory requirements.

The role drives continuous improvement, quality mindset, and data-driven decision making, with responsibility for strategy, audits, and CAPA

Qualifications

• 7+ years in the biopharmaceutical or pharmaceutical industry.
• 3+ years of people management experience in a GMP-regulated environment.
• 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 in a GMP setting.
• Working knowledge of ISO standards for injection systems and quality management systems.

Responsibilities

• Directly manage IQC and physical testing operations staff, providing direction and development.
• Foster a culture of quality, accountability, and operational excellence across IQC areas.
• Set team and individual performance goals aligned to KPIs and conduct reviews.
• Support hiring, onboarding, and training of IQC personnel and ensure training records are compliant.
• Articulate complex technical issues to leadership, clients, and regulators.

Skills

QC management

Regulatory compliance

GMP experience

Statistical analysis

LIMS/JMP/Minitab

Education

Bachelor’s degree in Science

Tools

LIMS

JMP

Minitab

Job description

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.

Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients, for yourself, and for INCOG’s clients.

WHAT?:

• 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 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.

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 but not limited to: container closure integrity testing (CCIT); glide force, break-loose force, and extrusion force testing; needle cap and needle shield 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 is maintained, calibrated, and qualified in accordance with site equipment qualification and calibration programs; partner with Engineering and Metrology as needed.
• 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, applicable ISO standards (e.g., ISO 11608 series, ISO 23908, ISO 13485), and client and regulatory requirements.
• Ensure physical testing method development, validation, and transfer activities are executed in alignment with project timelines and quality standards.

Investigations & CAPA

• Lead or provide management oversight for laboratory investigations associated with OOS, OOT, and non-conformance events within IQC and physical testing scope, 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.
• Monitor CAPA effectiveness and provide escalation to the Senior Director of Quality Control as appropriate.

Quality Systems & Documentation

• Utilize and maintain QMS, LIMS, and related automated systems to manage policies, procedures, test records, and technical reports through their full lifecycle.
• Review and approve QC documentation including sampling plans, test methods, specifications, CoA templates, physical testing protocols, and investigation reports.
• Support preparation, coordination, and hosting of FDA, EMA, and client GMP audits and inspections related to IQC and physical testing activities; serve as a subject matter expert during regulatory interactions.
• Ensure all QC operations comply with FDA 21 CFR Part 211, ICH guidelines, applicable pharmacopeial standards (USP, EP, JP), and EU GMP Annex 1.

Cross-Functional Collaboration

• 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, method availability, and equipment qualification ahead of manufacturing milestones.

YOU:

Ideally, candidates will have a Bachelor’s degree in Science (Biology, Chemistry, Pharmaceutical Sciences, Engineering, etc), as well as the following:

• 7+ years of experience in the biopharmaceutical or pharmaceutical industry.
• 3+ years of people management experience, including direct management of individual contributors in a GMP-regulated environment.
• 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 in a GMP setting.
• 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 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; failure to pass annual assessments may result in restriction from applicable duties.

Additional Preferences

• 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 or equivalent standards.
• Familiarity with USP 1207 Container Closure Integrity Testing guidance.
• Experience with AQL establishment with ANSI requirements and defect criteria based on PDA guidance.
• Experience with defect classification criteria development based on PDA Technical Report No. 79 or equivalent guidance.
• Experience with ERP systems (e.g., SAP) in a GMP manufacturing or CDMO environment.
• Prior CDMO experience with multi-client product management responsibilities.

Why INCOG?

• Paid vacation days, amount based on tenure, and paid sick time
• PTO (based on tenure) & 11 holidays (9 observed + 2 floating)
• 401(k) plan with company match up to 3.5% of salary, vested immediately
• Choice of health & wellness plans
• FSA and HSA programs

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.