Associate Director, Quality Control

Role: Associate Director, Quality Control, providing strategic and operational leadership for QC laboratory functions including analytical chemistry, microbiology, and bioanalytical testing to support pharmaceutical manufacturing. Responsibilities: oversee routine, in-process, release, and investigative testing; ensure compliance with cGMP, global standards, and regulatory requirements; serve as a subject-matter expert during inspections and audits; drive continuous improvement initiatives utilizing data analytics, Lean, and Six Sigma; develop budgets, manage staffing, and lead team development. Requirements: Bachelor's in life sciences, chemistry, or related field; 10+ years in regulated lab operations within pharma, biotech, or biologics; 6+ years of management experience, preferably leading large or 24/7 labs; deep knowledge of cGMP, regulatory standards, and laboratory systems such as TrackWise and SAP. Preferred: Master's or Ph.D., experience with endotoxin and sterility testing, and familiarity with digital lab tools. High-Value: biologics or small molecule drugs, regulated environment, active involvement in regulatory inspections, and laboratory compliance. Work Setup: onsite in Brooklyn Park, MN, with approximately 5-10% travel required for meetings, inspections, or training.