Lead, QCTS Data Integrity & Computerized Systems

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  Lead , Quality  Control  Technical Services (QCTS)  – Data Integrity  is responsible for  ensuring that QC laboratory systems , instruments, software, and associated data workflows meet  regulatory expectations for data integ rity and  GxP  compliance.  This role provides expert oversight and support across  QC  laboratory  for computerized system implementation, instrument qualification, assay data workflows, software validation , and data governance activities.   The lead partners closely with QC operations, Validation, IT, and system owners to ensure that QC systems are designed and maintained, and monitored in alignment with  21 CFR Part 11 and EU Annex 11 , ALCOA+ prin ciples, and corporate data integrity standards .    The role supports audits and inspections, authors technical documentation, resolves data-related  issues, and contributes leadership through scientific and systems  expertise . ESSENTIAL JOB FUNCTIONS  Serve as the QCTS Data Integrity and Computerized System  Validation  SME, ensuring QC laboratory systems  comply with  21 CFR part 11,  EU Annex 11 and internal DI policies.   Provide  expertise  and support for QC computerized systems,  including  instrument software, standalone ana lytical instruments, and data acquisition/proce ssing tools , including Excel  spreadsheets . Partner with QC labs leads, system owners, Validation , and IT to ensure  robust lifecycle management of QC systems, including system qualification, validation, periodic review,  and configuration controls. Responsible  for overall lifecycle management of computer  system  validation activities in QC/GMP environment. Lead  implementation of change management  of QC instruments, software upgrades, and new laboratory technologies to ensure readiness for GMP use. Maintain and improve data integrity practices within the QC function, including  data review workflows, audit trails, user access, data storage, and backup/restore procedures. Support QC investigations (deviations, OOS/OOT, CAPAs) involving data integrity , system performance, or data workflow failures; provide technical root-cause contributions. Lead authoring and maintenance of QCTS procedures, work instructions , validation protocol, validation summary reports , and guidance documents  relating  to computerized systems, instrument qualification  (IOQ, PQ) , and data integrity. Coordinate with external qualified service  providers to ensure  QC systems  are  validated . Support internal and external audits /inspections as the QCTS Data Integrity SME, providing evidence for QC systems, validation documentation, and data governance controls. Deliver training, guidance, and technical mentorship to QC analyst s and system users to strengthen data integrity awareness and consistent  system usage across QC.   SPECIAL JOB REQUIREMENTS Adaptability required as work schedule may change based on business needs Criminal background check required Other duties as assigned KNOWLEDGE, SKILLS AND EXPERIENCE EDUCATION / CERTIFICATIONS / LICENSES Degree in science-related field ON-THE-JOB EXPERIENCE 1 0 +  years of experience in IT Systems/CSV, Enterprise Solutions ( Veeva ,  CDS ), QMS (electronic and paper), and data integrit y ,  Excel spreadsheet validation SKILLS / ABILITIES Prior experience working in a CDMO environment   10+  years working in a Good Manufacturing Practices (GMP) environment   Subject matter expert in 21 CFR Part 11, GAMP  5 , EU A nnex 11   Subject matter expert in Good Documentation Practices (GDP)   Excellent computer literacy (MS Word, Excel,  Smart S heets )   Excellent  project management tools (MS project,  Smart S heets )   Excellent executive communication skill s , both written and oral   Pay Range: The annual salary range for this position is $110,000-$150,000. PHYSICAL DEMANDS  While performing the duties of this job, the employee is required to meet the following physical demands: Work Environment   Regularly sit for  long periods  of time   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 Rarely 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-mai l     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 dedica