Claudette Kile has been appointed vice president of Quality & Regulatory at Gallus BioPharmaceuticals to support the company’s growth of its contract manufacturing services. Ms. Kile will be responsible for the planning, implementation and daily operations of the Quality & Regulatory organization at Gallus headquarters in St. Louis and the Princeton, NJ facility.
Ms. Kile has 27 years of industry experience in medical devices, biologics, and pharmaceuticals, with specialized expertise in building global compliant quality systems. Most recently, she was senior director of quality at Jazz Pharmaceuticals, where she led the oversight of global clinical trials and drug safety and pharmacovigilance activities. Previously she held roles in quality at Emergent Biosolutions, where she oversaw the supply of vaccines and antibody therapy products from preclinical through commercial, as well as managed her own consultancy focused on regulatory affairs, compliance, and quality assurance.
“Gallus has a strong track record in process development, clinical and commercial manufacturing of licensed biopharmaceuticals at both sites, and the addition of Claudette Kile to our team strengthens our commitment to maintaining exemplary compliance for our pharma and biotech clients as their products mature through the clinic towards licensure,” said Mark Bamforth, president and chief executive officer of Gallus.