Senior Manager, Quality Assurance Shop Floor
Core
Senior Manager leading front-line managers and teams to ensure highest quality standards in cGMP Cell Therapy manufacturing, release testing, and packaging at the Devens Cell Therapy Facility.
Role type
Senior Manager, Quality Assurance Shop Floor (People Leader)
Builds
Autologous drug product (manufacturing, release testing, packaging)
Domain
Biopharmaceuticals / Cell Therapy / cGMP Manufacturing
Required skills
cGMP compliance, quality management systems, team leadership, cross-functional collaboration, problem-solving, training program development, deviation/CAPA management, aseptic environment knowledge
Preferred skills
Aseptic/sterile environment experience, microbial controls, contamination mitigation strategies
Technologies
Quality Management Systems, Batch Record Management Systems
Responsibilities
Lead and mentor day-shift managers and teams; Uphold and improve quality standards through cross-functional collaboration; Develop and implement training programs; Solve complex quality issues and drive continuous improvement; Provide on-the-floor quality oversight and triage unexpected events; Act as subject matter expert for audits, inspections, and compliance activities; Interview, hire, coach, and develop staff.
Seniority
Senior Manager, hands-on leadership