Senior/Lead Associate, QA Operations

Genezen•Indianapolis, IN

About The Position

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. PURPOSE Be an integral part of the Quality Assurance and Quality Systems team by providing advanced quality oversight and technical expertise to operations, manufacturing, and quality control activities. Ensure product quality and compliance with applicable regulations and Genezen quality policies and procedures. Serve as a subject matter expert and day-to-day leader for a team of Quality Operations Associates by providing technical guidance, coaching, training, work prioritization, and performance support while fostering a culture of quality, collaboration, and continuous improvement.

Requirements

Bachelor’s degree in science or related field
Experience in industries regulated in-part by, 21 CFR Part 11, 21 CFR 210, 21 CFR 211, 21 CFR 600, 21 CFR 610, Eudralex Volume 4, ICH Quality Guidelines, and Guidance to Industry dockets, as applicable for early phase clinical trials
6 - 8+ years of working experience in a Pharmaceutical or Biologics industry in a Quality Assurance role
Manage multiple projects, set priorities, and work in fast-paced, ever-changing environment
Communicate confidently and effectively with management, peers and key stakeholders
Demonstrate effectiveness in task completion, decision-making, empowerment of others, deviation/nonconformance management, training, and problem solving
Work independently and be self-motivated
Proven ability to work cross-functionally to achieve business outcomes

Nice To Haves

Familiarity of eQMS systems such as Veeva
Knowledge of clean room controls, aseptic processing, and EMA and ISO standards for cleanrooms
Knowledge of cGxPs, clean room controls, aseptic processing, and EMA and ISO standards for cleanrooms
Previous experience providing technical leadership, mentoring, or supervisory responsibilities
Experience working in with early phase clinical trial production and testing
Previous experience with a startup CDMO and/or in the field of Gene Therapy

Responsibilities

Serve as the technical lead for Quality Operations Associates, providing coaching and guidance on GMP compliance, quality systems, investigations, and documentation.
Prioritize daily QA floor support activities to ensure appropriate coverage across manufacturing operations.
Review work performed by junior associates for accuracy, completeness, and compliance prior to final approval, where applicable.
Mentor team members in deviation investigations, CAPAs, change controls, and root cause analysis.
Lead continuous improvement initiatives that enhance quality systems, operational efficiency, and inspection readiness.
Partner with Quality leadership to identify training needs and competency development for the team.
Assist management with resource planning, scheduling, workload balancing, and escalation of quality issues.
Serve as a primary QA representative for cross-functional projects and strategic initiatives.
Lead complex investigations, high-impact deviations, and quality risk assessments.
Act as the QA Operations delegate for management during periods of absence as assigned.
Provide Quality oversight for Manufacturing, Quality Control, and related operations to ensure compliance with GMPs, SOPs, and regulatory requirements.
Guide production personnel on GMP compliance, SOP adherence, and process improvements.
Review batch records, logbooks, and cleanroom documentation for accuracy, completeness, and compliance.
Ensure quality documentation complies with cGMP, GDP, and Genezen quality standards.
Develop, review, approve, and maintain SOPs and other controlled Quality documents.
Review, approve, and release raw materials, quality control results, and Certificates of Analysis.
Review and approve executed batch records and provide guidance to reduce documentation errors.
Support final disposition activities for master cell banks and viral vector products.
Deliver GMP and GDP training for new hires and existing employees, as needed.
Lead investigations of Quality Events, including deviations and environmental excursions, using root cause analysis and cross-functional collaboration.
Drive Quality Events to timely and effective closure in accordance with established deadlines.
Review and approve, and implement (as applicable) specifications for labels for media fills, master cell banks and viral vector products
Review and approve Media Fill and Stability protocols and reports; serve as a Quality observer as needed.
Initiate, review, approve, and monitor CAPAs and Change Controls to ensure timely implementation and effectiveness.
Provide guidance to cross-functional teams on Quality Systems and GMP compliance.
Support internal audits, customer audits, and regulatory inspections.
Collaborate with Operations, Manufacturing, QC, Regulatory, and QA teams to ensure compliance with approved procedures and regulatory requirements.