Principal Pharmaceutical Quality Assurance Auditor (Remote)

Our client, a globally recognized pharmaceutical innovator, is actively seeking a distinguished Principal Pharmaceutical Quality Assurance Auditor to join their esteemed, fully remote team. This senior-level position plays a critical role in upholding the highest standards of quality and compliance across all stages of drug development and manufacturing. You will be responsible for planning, conducting, and documenting comprehensive audits of internal processes, contract manufacturing organizations (CMOs), and suppliers to ensure adherence to cGMP, FDA, EMA, and other relevant global regulatory requirements. Key duties include evaluating quality systems, identifying compliance gaps, recommending corrective and preventive actions (CAPAs), and tracking their effective implementation. This role requires extensive expertise in pharmaceutical quality assurance, regulatory affairs, and audit methodologies. You will also be involved in developing and refining audit programs, training other auditors, and providing expert guidance on complex quality and compliance issues. The ideal candidate possesses a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field, coupled with a minimum of 10 years of progressive experience in pharmaceutical quality assurance and auditing. Deep knowledge of ICH guidelines, cGMP regulations, and aseptic processing is essential. Exceptional analytical skills, meticulous attention to detail, and outstanding written and verbal communication abilities are required to effectively communicate findings and influence stakeholders across the organization. This is a unique opportunity for a seasoned QA professional to make a significant impact on global health outcomes while enjoying the flexibility of a remote work arrangement.