Manager, QC Systems and Support
Core
Manage the QC Systems and Support team to ensure safety, quality, and performance targets are met in a cell therapy manufacturing environment.
Role type
Manager, Quality Control Systems and Support
Builds
Quality Control systems and support for cell therapy manufacturing
Domain
Life Sciences / Cell Therapy / Pharmaceutical Manufacturing
Required skills
Leadership, cGMP compliance, Change control management, CAPA management, Data integrity, LIMS/SAP, Risk management, Lean/Six Sigma
Preferred skills
Advanced degree, Lean/Six Sigma, Risk Management concepts
Technologies
SAP, LIMS
Responsibilities
Provide direct management of the QC Systems and Support team and oversee daily activities. Develop and execute a work plan ensuring safety, quality, and performance targets are achieved. Author, review, and approve records and technical documents ensuring compliance. Own and evaluate change controls, investigations, deviations, and CAPAs. Hire, coach, mentor, and develop team members. Lead team meetings and cross-functional operational meetings. Ensure employees are properly trained and qualified. Identify and mitigate risks impacting lab operations and safety. Lead resources in the design, implementation, and continuous improvement of Quality Control systems. Apply technical knowledge to troubleshoot non-routine and complex issues. Ensure inspection readiness and support internal and external inspections.
Seniority
Manager, 6-8+ years experience