Jobs at American Regent, Inc.

Lead and manage clinical quality assurance activities including study-specific audit planning and execution across Pharmacovigilance, Clinical Operations, Quantitative Sciences, and Regulatory Affairs. Evaluate regulatory compliance, generate audit reports, manage CAPAs, support inspection readiness, and drive continuous process improvement and SOP development. Provide training, onboarding, and independent regulatory compliance advice for human and animal clinical programs and post-marketing safety activities.

Lead manufacturing quality activities for aseptic pharmaceutical production: manage investigations and CAPAs, perform root cause analysis, write technical documents, support training and gown qualifications, ensure cGMP compliance, partner with manufacturing and cross-functional teams, and drive continuous improvement and environmental monitoring programs.

Entry-level Formulation/Manufacturing role executing compounding tasks under cGMP and SOPs. Duties include weighing bulk, cleaning equipment and filters, calibrating scales and pH meters, sampling, recording batch data with integrity, coordinating with supervisors and other departments, and maintaining cleanliness and safety in compounding areas.

Lead day-to-day commercial aseptic manufacturing operations (compounding, sterile filling, inspection, packaging). Provide supervisory leadership, ensure GMP/regulatory compliance (FDA, OSHA, EPA, OFCCP), drive continuous improvement, manage staffing and training, oversee quality activities (CAPA, validations, change control) and meet production, safety, and financial targets.

Senior leader responsible for site-wide quality and compliance for sterile and lyophilized small and large molecule products, PFS and combination products. Oversees QA/QC functions, regulatory inspection management, deviation/CAPA/change control systems, continuous improvement, product release, and cross-functional quality initiatives to maintain cGMP and regulatory compliance.

Serve as liaison between business and IT to define, document, and validate requirements for GxP‑regulated computerized systems. Support CSV activities across system lifecycle, author validation deliverables, assess change impacts and data integrity risks, participate in audits/inspections, and partner with Quality, IT, and business stakeholders to maintain compliant, inspection‑ready systems.

Support aseptic pharmaceutical manufacturing by developing and maintaining SOPs, troubleshooting and optimizing process/filling equipment, ensuring GMP compliance, leading equipment installation/qualification, managing projects and vendor activities, tracking KPIs, supporting maintenance and QA investigations, and training staff.