From Genezen's posting. “We” and “our” refer to the employer.
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 escalate 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 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.
Regulatory Compliance & Inspection Readiness
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.
Data Integrity, Metrics, & Continuous Improvement
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.
Cross-Functional & Client Support
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.
People & Organizational Leadership
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.
KNOWLEDGE, SKILLS, AND EXPERIENCE
EDUCATION / CERTIFICATIONS / LICENSES
Essential/Desired
BS in Molecular Biology, Biochemistry, Chemistry or related field
Essential
MS in Molecular Biology, Biochemistry, Chemistry or related field
Desired
ON-THE-JOB EXPERIENCE
Minimum 3 - 5 years in a leadership role
Essential
Minimum 5 - 8 years progressive experience in quality control, or related discipline within biopharma or CDMO environments
Essential
Demonstrated experience with laboratory investigations and quality systems, including OOS/OOT investigations, deviations, CAPAs, root cause analysis, and data integrity requirements
Essential
Demonstrated experience leading GMP Quality Control laboratory operations, including in-process, release, stability, and/or microbiological testing
Essential
SKILLS / ABILITIES
Extensive knowledge of cGMP, GLP, FDA, EMA, and ICH requirements.
Essential
Excellent communication skills and ability to thrive in fast paced, dynamic environment
Essential
Experience with environmental monitoring programs, contamination control, and aseptic manufacturing support.
Essential
Familiarity with laboratory systems, LIMS, data integrity principles, and automation technologies.
Essential
Proven leadership experience, with a track record of building and managing high-performing teams
Essential
PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:
Work Environment
Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
Occasionally exposed to extremely loud noise levels
Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required
Movement
Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl
Lifting
Frequently lift and/or move up to 10 pounds
Occasionally lift and/or move up to 25 pounds
Vision
Frequently utilize close vision and the ability to adjust focus
Communication
Frequently required to communicate by talking, hearing, using telephone and e-mail
GENEZEN'S
CURES
VALUE-BASED COMPETENCIES
C ommitted to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
U rgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
R esilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
E xecute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.
S olutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.
Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
This position requires a criminal background check.
Genezen participates in EVerify.
Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.
Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.
Employer application notice
Equal opportunity and accommodations
Genezen is an Equal Opportunity Employer.
About this listing
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
