Sr Manager QA Technical Operations
Core
Provide leadership to a team of Quality managers overseeing Quality Control projects, daily activities, and operations for Cell Banking, Change Controls, Technology Transfer, Automation, Validation, and Maintenance programs.
Role type
Senior Manager, Quality Technical Operations
Builds
Quality assurance and compliance frameworks for biopharmaceutical manufacturing and technology transfer
Domain
Biopharmaceuticals / Cell Therapy / cGMP Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biopharmaceutical operations management, Quality Assurance operations, cGMP regulations knowledge, FDA/EMA regulatory experience, Risk management, Technical transfer oversight, Team leadership, SOP development, Change control management
Preferred skills
Biotech bulk and finished product manufacturing knowledge, Analytical testing expertise, SAP/LIMS/Maximo/Veeva Vault proficiency
Technologies
SAP, LIMS, Maximo, Syncade, DeltaV, Veeva Vault
Responsibilities
Supervise personnel approving change controls, protocols, reports, and investigations; Manage quality approval of technical transfer documentation (PPQ, PD, FFR, MBR); Coordinate with stakeholders in clinical and commercial tech transfer meetings; Track and manage risks and decisions from technical transfer sub-teams; Represent quality in Tech Transfer Governance and project meetings; Review and approve site and department SOPs; Prepare for and host regulatory inspections and audits; Hire, integrate, and develop high-quality talent.
Seniority
Senior Manager, hands-on leadership with strategic oversight