Director, QA Microbiology (Drug Product Manufacturing)

Director QA Microbiology Responsibilities Own and elevate the site-wide bioburden control and sterility assurance program; execute targeted remediation to sustain control. Maintain alignment with evolving industry and regulatory standards for microbial control; pilot and deploy new monitoring technologies within the IOPS system. Strengthen environmental monitoring SOPs and validation for fitness for purpose and regulatory conformance. Trend and interpret bioburden and environmental monitoring (EM) data; elevate and explain excursions; drive cross‑functional actions and brief senior leadership. Build a value‑added microbiology program aligned with quality, regulatory, and legal requirements. Define microbiology KPIs and dashboards; lead continuous improvement. Embed quality tools and formal risk management (e.g., FMEA, HACCP, fault tree analysis) across program elements. Proactively update strategies, procedures, and controls to remain compliant and effective. Make timely, science‑based decisions to protect patient safety; communicate risk, rationale, and outcomes. Resolve complex technical challenges while harmonizing with global regulatory standards to support reliable product release. Serve as the drug product site’s microbiology authority and primary interface to regulators and internal/corporate partners. Translate program vision into executable action plans with clear owners, timelines, and success metrics. Ensure transparency of the Microbiological Control Strategy and engage the organization in execution. Lead, develop, and upskill managers and specialists; allocate resources based on priorities, risk, and business needs. Set high performance standards, coach teams, and enforce accountability. Qualifications Bachelor’s degree in microbiology, medical technology, biology, or related field. Director experience in pharmaceutical/biotech industry: Associate Director: 10+ years Director: 12+ years Preferred Qualifications Comprehensive knowledge of microbiological expectations across drug development, pharmaceutical technology, and drug manufacturing; knowledge of CMC and GMP; strong understanding of drug laws, global regulations, and guidelines. Experience building quality culture and quality management capabilities. Comprehensive knowledge/experience with CMC content for submissions (IND, BLA, CBE, PAS) and equivalent European submissions. Ability to think and operate in a rapidly evolving/ambiguous environment; strong leadership and written/oral communication. Intellect for quality risk identification, mitigation, and management. #J-18808-Ljbffr Scorpion Therapeutics