Senior Associate, Quality Operations

Responsibilities

• Provide quality oversight for Manufacturing, Quality Control, and other operational areas through on-the-floor presence
• Perform assessments to ensure compliance with GMP, SOP, and regulatory requirements
• Review cleanroom documentation, batch records, and logbooks for accuracy and contemporaneous completion
• Develop, optimize, and approve SOPs and other controlled documents
• Review and release critical raw materials, quality control tests, and Certificates of Analysis
• Initiate and perform Root Cause Analysis for Quality Events, including Deviations and Environmental Excursions
• Drive Quality Events to closure and manage CAPAs and Change Management activities
• Lead site internal audits and support customer audits or regulatory inspections
• Provide site GMP and GDP training to new hires and existing staff

Requirements

• Bachelor’s degree in science or a related field
• 6+ years of experience in a Quality Assurance role within the Pharmaceutical or Biologics industry
• Experience in industries regulated by 21 CFR Part 11, 210, 211, 600, 610, and Eudralex Volume 4
• Ability to manage multiple projects in a fast-paced environment
• Strong cross-functional communication and problem-solving skills

Preferred Qualifications

• Familiarity with eQMS systems such as Veeva
• Knowledge of cleanroom controls, aseptic processing, and EMA/ISO standards
• Experience with early phase clinical trial production and testing
• Previous experience in a startup CDMO or the Gene Therapy field
• Leadership or mentoring experience

About the Company

Genezen provides process development, GMP viral vector production, and cell transduction for gene and cell therapy clinical trials to help bring new cures to patients.