Manager/Senior Manager, Quality Control

genezenlabs; Indianapolis (IN); On-site; USD 120,000 - 180,000; Full time

Job summary

Genezen in Indianapolis, IN, is seeking a Manager/Senior Manager, Quality Control to provide technical and operational leadership for QC activities supporting viral vector programs.

The role ensures timely, compliant testing, oversees investigations, CAPAs, stability programs, and maintains data integrity and readiness for inspections while developing QC personnel.

Qualifications

• Experience leading QC laboratory operations in a regulated environment.
• Ability to prioritize within manufacturing schedules and client commitments.
• Strong collaboration with QA, Manufacturing, and Regulatory teams.

Responsibilities

• Lead day-to-day QC laboratory operations supporting in-process, release, stability testing.
• Ensure testing is performed per approved methods and cGMP requirements.
• Oversee QC investigations including OOS/OOT and CAPA development.
• Manage stability programs, data review, and trend reporting.
• Provide governance for laboratory equipment, systems, and environmental monitoring.

Job description

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

WORKING AT GENEZEN

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

JOB SUMMARY

The Manager/Senior Manager, Quality Control provides technical and operational leadership for Quality Control laboratory activities supporting Genezen's viral vector programs. This role is responsible for ensuring the timely, compliant, and reliable execution of QC testing activities, including in-process, release, stability, and environmental monitoring testing, in accordance with cGMP requirements, approved procedures, and applicable regulatory expectations. This position provides oversight of QC laboratory operations, including testing execution, laboratory investigations, stability programs, data integrity, equipment and laboratory systems, and inspection readiness. The Manager/Senior Manager ensures QC activities are appropriately prioritized and resourced to support manufacturing schedules, client commitments, and product disposition while maintaining high standards for quality, compliance, and scientific rigor. The role partners closely with Quality Assurance, Manufacturing, Process Development, Regulatory Affairs, and other cross-functional stakeholders to resolve quality issues, support investigations and regulatory activities, and continuously improve laboratory performance. The Manager/Senior Manager also leads and develops QC personnel, establishing clear expectations and fostering a culture of accountability, collaboration, continuous improvement, and compliance.

ESSENTIAL JOB FUNCTIONS

Quality Control Laboratory Operations

• Lead day-to-day QC laboratory operations supporting in-process, release, stability, and other required testing activities.
• Establish laboratory priorities and allocate resources to support manufacturing schedules, product disposition, client commitments, and business needs.
• Ensure testing is performed accurately, efficiently, and in accordance with approved methods, specifications, procedures, and cGMP requirements.
• Monitor laboratory workload, testing timelines, and capacity and proactively address risks that could impact testing or product release.
• Provide technical oversight and troubleshooting support for complex laboratory issues and testing events.

QC Investigations & Quality Systems

• Provide oversight and technical direction for laboratory investigations, including OOS, OOT, deviations, and other atypical laboratory events.
• Ensure investigations are scientifically sound, thoroughly documented, completed within established timelines, and appropriately identify root cause and corrective actions.
• Develop, implement, and monitor CAPAs associated with QC laboratory operations and investigations.
• Partner with Quality Assurance and other functions to evaluate quality events, identify trends, and mitigate recurring issues.
• Support change controls and other Quality Management System activities impacting QC operations.

Stability Program Management

• Oversee execution of stability programs, including sample management, testing schedules, protocol adherence, data review, trending, and reporting.
• Ensure stability activities are executed in accordance with approved protocols, regulatory commitments, and applicable requirements.
• Identify and elevate stability trends, atypical results, or risks that may impact product quality or shelf-life.

Laboratory, Equipment & Systems Governance

• Oversee QC laboratory infrastructure and equipment lifecycle activities, including qualification status, calibration, preventive maintenance, and service requirements.
• Ensure laboratory equipment and systems remain in a state of control and are appropriate for their intended use.
• Coordinate laboratory equipment needs, capacity planning, and operational readiness.
• Ensure appropriate segregation and controls for GMP and non-GMP laboratory activities, as applicable.
• Partner with appropriate functions to maintain laboratory computerized systems and associated compliance requirements.

Microbiology, Environmental Monitoring & Contamination Control

• Provide leadership and oversight for environmental monitoring and microbiological QC activities, as applicable to assigned laboratory operations.
• Ensure appropriate monitoring, trending, escalation, and investigation of environmental