Quality Leader - Cellular Immunotherapy (GMP/GLP)

BioCytics Inc

Huntersville (NC)

On-site

USD 110,000 - 160,000

Full time

14 days+

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Benefits offered by this job

401(k)

Health insurance

Paid time off

Vision insurance

Job summary

BioCytics Inc. seeks a HAL Quality Manager to lead the Quality Management System across GMP/GLP operations for cellular immunotherapy products.

You will create quality processes, SOPs, QC programs, and training, ensuring FDA and internal standards are met in a fast-paced lab environment in Huntersville, NC. You will supervise quality personnel, drive deviations and CAPA, and support regulatory inspections and supplier qualification.

Qualifications

Minimum 7 years in regulated quality systems.
Experience developing and implementing GMP Quality Management Systems.
Cell therapy or biologics experience.
Startup GMP facility experience.
Experience supporting FDA inspections.
Experience with deviations, CAPA, Change Control, document control, risk management, training, supplier qualification, and internal auditing.
FACT or AABB experience preferred.
Minimum 3 years of leadership supervising quality personnel.

Responsibilities

Lead the development, implementation, and maturation of the HAL QMS for GLP/GMP.
Develop, implement, and monitor quality policies, procedures, forms, and work instructions.
Ensure cGMP, GLP, GTP, GDP compliance and regulatory standards.
Collaborate with leadership to set quality objectives and metrics.
Oversee document control, SOPs, batch records, specifications, validation docs.
Monitor quality indicators, QC charts, and trend analysis.
Manage deviations, investigations, CAPA, Change Control, and risk assessments.
Prepare quality metrics and reports for leadership reviews.
Maintain readiness for inspections and participate in regulatory audits.
Support supplier qualification and regulatory activities.