Senior Director, QC & Sterile Analytics

Medivant Healthcare; Chandler (AZ); On-site; USD 180,000 - 230,000; Full time

Job summary

Medivant Healthcare seeks a Director/Senior Director of Quality Control to lead QC Analytical Chemistry and Microbiology operations for sterile injectable manufacturing. This role ensures timely testing, product release, regulatory readiness, and continuous improvement across laboratory operations.

The position requires extensive GMP experience, leadership in regulated labs, and strong expertise in analytical testing, microbiology, and environmental monitoring to support manufacturing growth and

Qualifications

• Bachelor's degree in Chemistry, Microbiology, Pharmaceutical Sciences, or related field.
• 10+ years of QC experience in pharmaceutical manufacturing.
• 5+ years of leadership in GMP-regulated laboratories.
• Experience with sterile injectables, analytical testing, microbiology, and environmental monitoring.
• In-depth knowledge of FDA, USP, GMP, and data integrity requirements.
• Experience supporting regulatory inspections and audits.

Responsibilities

• Lead QC Analytical Chemistry and Microbiology laboratories.
• Oversee testing, product release, and stability programs.
• Manage budgets, staffing, capacity, and capital investments.
• Establish QC KPIs and drive operational excellence.
• Recruit, mentor, and develop laboratory personnel.
• Promote a culture of quality, accountability, and continuous improvement.
• Coordinate with QA and Manufacturing for batch release timelines.
• Oversee method validation, transfer, and lifecycle management.
• Maintain data integrity across all laboratory systems.
• Serve as QC SME during inspections, audits, and regulatory interactions.

Skills

GMP compliance

Leadership

Regulatory inspections

Data integrity (ALCOA+)

Quality systems management

Laboratory operations management

Analytical testing oversight

CAPA investigations

Cross-functional collaboration

Sterile injectable QC

Education

Bachelor's degree in Chemistry / Microbiology / Pharmaceutical Sciences

Master's or PhD preferred

Tools

LIMS

Empower

Job description

Medivant Healthcare seeks a Director/Senior Director of Quality Control to lead QC Analytical Chemistry and Microbiology operations for sterile injectable manufacturing. This role ensures timely testing, product release, regulatory readiness, and continuous improvement across laboratory operations.

The position requires extensive GMP experience, leadership in regulated labs, and strong expertise in analytical testing, microbiology, and environmental monitoring to support manufacturing growth and