Manager/Senior Manager, Quality Control

Genezen•Indianapolis, IN

3d•Onsite

About The Position

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.

Requirements

BS in Molecular Biology, Biochemistry, Chemistry or related field
Minimum 3 - 5 years in a leadership role
Minimum 5 - 8 years progressive experience in quality control, or related discipline within biopharma or CDMO environments
Demonstrated experience with laboratory investigations and quality systems, including OOS/OOT investigations, deviations, CAPAs, root cause analysis, and data integrity requirements
Demonstrated experience leading GMP Quality Control laboratory operations, including in-process, release, stability, and/or microbiological testing
Extensive knowledge of cGMP, GLP, FDA, EMA, and ICH requirements.
Excellent communication skills and ability to thrive in fast paced, dynamic environment
Experience with environmental monitoring programs, contamination control, and aseptic manufacturing support.
Familiarity with laboratory systems, LIMS, data integrity principles, and automation technologies.
Proven leadership experience, with a track record of building and managing high-performing teams

Nice To Haves

MS in Molecular Biology, Biochemistry, Chemistry or related field

Responsibilities

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.
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.
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 escalate stability trends, atypical results, or risks that may impact product quality or shelf-life.
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.
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 and microbiological results.
Support contamination control strategies and investigation of microbiological or environmental excursions.
Partner with Manufacturing and Quality Assurance to maintain appropriate controls supporting aseptic processing and product quality.
Ensure QC laboratory operations comply with cGMP, applicable FDA and international regulatory requirements, approved procedures, and internal quality standards.
Maintain a sustained state of inspection readiness across QC laboratory operations.
Serve as a QC subject matter expert during regulatory inspections, client audits, and internal audits.
Support regulatory filings, responses, data requests, and other documentation requiring QC input.
Ensure timely and effective resolution of audit and inspection observations associated with QC operations.
Ensure QC data and records meet applicable data integrity requirements, including ALCOA+ principles and electronic records requirements.
Monitor QC performance through meaningful metrics such as testing turnaround time, right-first-time performance, investigation cycle time, testing backlog, and deviation trends.
Identify and implement process improvements that increase laboratory efficiency, compliance, quality, and reliability.
Support implementation and effective use of laboratory systems, digital solutions, and automation where appropriate.
Use laboratory performance data and trends to identify risks and drive corrective or preventive improvements.
Partner with Manufacturing, Quality Assurance, Process Development, Regulatory Affairs, Supply Chain, and other functions to ensure QC readiness and timely resolution of quality or testing issues.
Provide QC expertise and status updates for client programs, project teams, and internal stakeholders.
Communicate testing risks, laboratory constraints, investigation status, and potential impacts to timelines in a timely and transparent manner.
Support technology transfer and commercialization activities from the QC testing/readiness perspective, including laboratory readiness, testing capacity, specifications, and execution requirements.
Lead, coach, and develop QC scientists, associates, technicians, and/or supervisors, as applicable.
Establish clear performance expectations, priorities, roles, and accountability for QC personnel.
Ensure personnel are appropriately trained and qualified to perform assigned GMP activities.
Manage performance, provide ongoing coaching and feedback, and support employee development and succession planning.
Promote a culture of quality, integrity, collaboration, accountability, continuous improvement, and operational excellence.
Assess staffing, capability, and training needs to ensure the QC organization can effectively support current and future business requirements.