Director, QC & Microbiology — Strategy & Lab Excellence

Socket.dev

San Diego (CA)

On-site

USD 151,000 - 189,000

Full time

14 days+

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Benefits offered by this job

Paid time off

Health insurance

FSA

401(k)

Job summary

PCI Pharma Services seeks a Director of QC & Microbiology to lead strategic and operational aspects of Quality Control Chemistry and Microbiology. You will ensure regulatory compliance, laboratory capacity, and organizational capability to support current operations and growth.

This role requires strong technical and people leadership, with responsibility for inspections, investigations, and continuous improvement.

Qualifications

Bachelor's degree required; MS/PhD preferred.
Typically 12+ years pharma/biotech/CDMO lab leadership.
Experience overseeing large departments and GMP environments.
Subject matter expert in regulatory inspections and client audits.
Experience with LIMS, CDS, SDMS systems.

Responsibilities

Set strategy for QC Chemistry and Microbiology aligned with site priorities.
Ensure staffing, capacity, instrumentation, and capabilities for current and future operations.
Lead budgeting, capital investments, and resource allocation.
Represent QC and Microbiology in inspections, audits, and governance.
Oversee testing across raw materials, in-process, release, stability, and environmental monitoring.
Validate and transfer analytical methods; manage OOS/OOT investigations and deviations.
Maintain data integrity and ensure compliance across lab records and reports.
Drive lab modernization, automation, and continuous improvement initiatives.
Develop leaders and build a high-performing QC/Microbiology organization.