Hiring: AVP - Global ATMP Quality Company: BioSpace Location: Indianapolis, IN Job Posted Time: 2026-09-10 11:44:25 Employment Type: Full-time Target Skills & Keywords : Quality Assurance About the job Experience: •15 years of experience in GMP manufacturing or quality operations within the pharmaceutical or biotechnology industry. •5 years of quality leadership experience with demonstrated ability to manage regulatory communications and inspections. Required Skills: •Quality Functions and Systems Oversight •Quality Leadership and Modality Expertise •Organization Development and People Leadership •Compliance, Regulatory Liaison, and Audit Readiness Qualifications: •Minimum of a Bachelor’s Degree in a science-related field such as Chemistry, Biological Sciences, Microbiology, Engineering, or related Life Sciences. •Minimum of 15 years of experience in GMP manufacturing or quality operations within the pharmaceutical or biotechnology industry. •Minimum of 5 years of quality leadership experience with demonstrated ability to manage regulatory communications and inspections. •Previous QA experience with biologics, cell therapy, gene therapy (AAV), or related advanced therapy modalities. •Demonstrated strong leadership skills with the ability to build and scale organizations. •An understanding of the requirements of regulatory agencies such as the FDA, EMA, ICH, and other global health authorities, particularly in the area of cGMPs for biological and advanced therapy medicinal products. •Demonstrated solid judgment, initiative, and ability to organize and prioritize multiple tasks across a complex, matrixed organization. •Must exhibit strong teamwork, communication, and interpersonal skills with the ability to influence cross-functionally and externally. •Advanced degree (M.S., Ph.D., or Pharm.D.) in a relevant scientific discipline. •Previous experience in QC, analytical development, TS/MS, or Regulatory Affairs. Compensation: •$241,500 - $354,200 / year •Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!