Director, Quality Management Systems

Role: Director of Quality Management Systems at a biopharma developing RNAi therapeutics, responsible for leading GxP QMS strategies to ensure compliance across clinical and commercial operations. Responsibilities: develop and optimize global QMS processes aligned with regulatory standards; oversee document control, training, non-conformance, CAPA, audits, and change management; monitor regulatory trends and lead risk assessments; collaborate with manufacturing, analytical, supply chain, regulatory, and development teams; build and mentor a high-performing QMS team, fostering a culture of quality and continuous improvement. Requirements: Bachelor's in life sciences, pharmacy, or chemistry; 10+ years in pharma/biotech industry, with 6+ years in QMS leadership, preferably overseeing pre-approval inspections or GMP compliance; deep knowledge of GMP, GDP, ICH, FDA, EU MDR, ISO standards; strong leadership, communication, and strategic skills; ability to work in a fast-paced, evolving environment with occasional travel. Preferred: advanced degrees (PhD/MS), experience with electronic QMS platforms (e.g., Veeva, TrackWise), biologics or RNA-based therapeutics, and PAI preparation. Work setup: based in Wisconsin, with a competitive salary range of $180,000–$210,000 USD.