Director, QC & Microbiology: Strategy & Compliance Leader

PCI Pharma Services; San Diego (CA); Vor Ort; USD 151.000 - 189.000; Vollzeit

Benefits dieser Stelle

Health insurance

Dental & Vision coverage

401(k) plan

Paid time off

Zusammenfassung

PCI Pharma Services seeks a Director of QC & Microbiology to provide strategic and operational leadership for the site’s QC Chemistry and Microbiology functions. You will oversee testing, environmental monitoring, investigations, and laboratory systems to ensure regulatory compliance, capacity, and continuous improvement.

The role requires strong regulatory and GMP experience, people leadership, and a track record of building high-performing teams while maintaining inspection readiness and risk

Qualifikationen

• Bachelor’s degree in chemistry, microbiology, biology, biochemistry, pharmaceutical sciences, or a life sciences field is required; advanced degrees preferred.
• Typically 12+ years of progressive pharmaceutical/biotech/CDMO lab leadership experience.
• Experience overseeing large departments with direct and indirect reports.
• Significant leadership in QC Chemistry and Microbiology in GMP environments.
• Experience with analytical testing, microbiological control, environmental monitoring, method transfer, stability, investigations, and data integrity.
• Subject matter expert in regulatory inspections, client audits, and compliance remediation.
• Experience with LIMS, CDS, and SDMS electronic systems.

Aufgaben

• Set strategy and lead QC Chemistry and Microbiology in line with site priorities.
• Ensure staffing, capacity, instrumentation, and capabilities for current and future needs.
• Lead budgets, capital investments, and resource allocation.
• Represent QC and Microbiology in regulatory inspections, audits, and governance.
• Collaborate with Quality, Manufacturing, Validation, Engineering, and Supply Chain to meet site objectives.
• Oversee testing across raw materials, in-process, release, stability, and environmental monitoring.
• Ensure methods are validated, transferred, maintained, and scientifically sound.
• Govern contract labs and external testing partners.

Kenntnisse

Strategic leadership

Regulatory compliance

Quality systems

GMP knowledge

Ausbildung

Bachelor’s degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or life sciences

Tools

LIMS

CDS

SDMS

Jobbeschreibung

PCI Pharma Services seeks a Director of QC & Microbiology to provide strategic and operational leadership for the site’s QC Chemistry and Microbiology functions. You will oversee testing, environmental monitoring, investigations, and laboratory systems to ensure regulatory compliance, capacity, and continuous improvement.

The role requires strong regulatory and GMP experience, people leadership, and a track record of building high-performing teams while maintaining inspection readiness and risk